research nurse clinical study

How to Become a Research Nurse

What is a research nurse.

• Career Outlook

Research Nurses, also referred to as Clinical Nurse Researchers or Nurse Researchers, develop and implement studies to investigate and provide information on new medications, vaccinations, and medical procedures. They assist in providing evidence-based research that is essential to safe and quality nursing care. This guide will explain what a Research Nurse does, how much they make, how to become one, and more!

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Research nurses play a pivotal role in developing new and potentially life-saving medical treatments. Typically, clinical research nurses have advanced degrees, assist in the development of studies regarding medications, vaccines, and medical procedures, and also the care of research participants. 

Nurses that know they want to be a clinical research nurse will often work as a research assistant, a clinical data collector, and/or clinical research monitor. It is essential to gain some bedside experience, but not as important as other nursing specialties. 

Clinical research nurses have advanced degrees such as an MSN or Ph.D. This is vital to those that want to conduct independent research. For that reason, most clinical research nurses do not work in this field until they are in their 40s-50s.

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What does a research nurse do.

Research Nurses primarily conduct evidence-based research through these two types of research methods:

• Quantitative: Meaning it’s researched that can be measured via statistical, mathematical, or computational techniques.
• Phenomenology
• Grounded Theory
• Ethnography
• Narrative Inquiry

Clinical research nurses perform a variety of tasks, all centered around research. These specific job responsibilities include:

• Collaborating with industry sponsors and other investigators from multi-institutional studies
• Educating and training of new research staff
• Overseeing the running of clinical trials
• Administering questionnaires to clinical trial participants
• Writing articles and research reports in nursing or medical professional journals or other publications
• Monitoring research participants to ensure adherence to study rules
• Adhering to research regulatory standards
• Writing grant applications to secure funding for studies
• Reporting findings of research, which may include presenting findings at industry conferences, meetings and other speaking engagements
• Adhering to ethical standards
• Maintaining detailed records of studies as per FDA guidelines, including things such as drug dispensation
• Participating in subject recruitment efforts
• Ensuring the necessary supplies and equipment for a study are in stock and in working order
• Engaging with subjects and understanding their concerns
• Providing patients with thorough explanation of trial prior to obtaining Informed Consent, in collaboration with treating physician and provides patient education on an ongoing basis throughout the patient’s course of trial.

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Research Nurse Salary

Glassdoor.com states an annual median salary of $95,396 for Research Nurses and Payscale reports that Clinical Research Nurses earn an average annual salary of $75,217 or $36.86/hr . 

Research Nurse Salary by Years of Experience

Research Nurses can earn a higher annual salary with increased years of experience.

• Less than 1 year  of experience earn an average salary of $68,000
• 1-4 years of experience earn an average salary of $73,000
• 5-9 years of experience earns an average salary of $73,000
• 10-19 years of experience earns an average salary of $80,000
• 20 years or more of experience earns an average salary of $78,000

Via Payscale

To become a Research Nurse, you’ll need to complete the following steps:

Step 1: Attend Nursing School

You’ll need to earn either an ADN or a BSN from an accredited nursing program in order to take the first steps to become a registered nurse. 

Step 2: Pass the NCLEX-RN

Become a Registered Nurse by passing the NCLEX examination.

Step 3: Gain Experience at the Bedside

Though not as important as in some other nursing careers, gaining experience is still a vital step for those wanting to become Nurse Researchers. 

Step 4: Earn an MSN and/or Ph.D

Research Nurses typically need an advanced degree, so ADN-prepared nurses will need to complete an additional step of either completing their BSN degree or entering into an accelerated RN to MSN program which will let them earn their BSN and MSN at the same time. 

Step 5: Earn Your Certification

There are currently two certifications available for Clinical Research Nurses. They are both offered by the Association of Clinical Research Professionals. 

• Clinical Research Association (CCRA)
• Clinical Research Coordinator (CCRC) 

These certifications are not specific to nurses but rather those that work in the research field. 

CCRA Certification

In order to be deemed eligible for the CCRA Certification exam, applicants must attest to having earned 3,000 hours of professional experience performing the knowledge and tasks located in the six content areas of the CRA Detailed Content Outline. Any experience older than ten years will not be considered.

What’s on the Exam?

• Scientific Concepts and Research Design
• Ethical and Participant Safety Considerations
• Product Development and Regulation
• Clinical Trial Operations (GCPs)
• Study and Site Management
• Data Management and Informatics

Exam Information

• Exam Fee: $435 Member; $485 Nonmember
• Exam Fee: $460 Member; $600 Nonmember
• Multiple choice examination with 125 questions (25 pretest non-graded questions)

CCRC Certification

In order to be deemed eligible for the CCRC Certification exam, applicants must attest to having earned 3,000 hours of professional experience performing the knowledge and tasks located in the six content areas of the CCRC Detailed Content Outline. Any experience older than ten years will not be considered.

Where Do Research Nurses Work?

Clinical Research nurses can work in a variety of locations, including:

• Government Agencies
• Teaching Hospitals
• Medical Clinics
• International Review Board
• Medicine manufacturing 
• Pharmaceutical companies
• Medical research organizations
• Research Organizations
• International Health Organizations
• Private practice
• Private and public foundations

What is the Career Outlook for a Research Nurse?

According to the BLS , from 2022 to 2032, there is an expected growth of 6% for registered nurses. With the aging population and nursing shortage, this number is expected to be even higher.

The BLS does identify medical scientists, which includes clinical research nurses, as having a growth potential of 10% between 2022-2032. 

What are the Continuing Education Requirements for a Research Nurse?

Generally, in order for an individual to renew their RN license, they will need to fill out an application, complete a specific number of CEU hours, and pay a nominal fee. Each state has specific requirements and it is important to check with the board of nursing prior to applying for license renewal.

 If the RN license is part of a compact nursing license, the CEU requirement will be for the state of permanent residence. Furthermore, some states require CEUs related to child abuse, narcotics, and/or pain management. 

A detailed look at Continuing Nurse Education hours can be found here .

Where Can I Learn More About Becoming a Research Nurse?

• American Nurses Association (ANA)
• Nurse Researcher Magazine
• National Institute of Nursing Research
• International Association of Clinical Research Nurses
• Association of Clinical Research Professionals
• Society of Clinical Research Associates
• American Association of Colleges of Nursing

Research Nurse FAQs

What is the role of a research nurse.

• Research nursing is a nursing practice with a specialty focus on the care of research participants. 

What makes a good Research Nurse?

• Research Nurses should be excellent communicators, have strong attention to detail, be self-assured, have strong clinical abilities, be flexible, autonomous, organized, and eager to learn new information.

How much does a Research Nurse make?

• Research nurses earn an average salary of $95,396 according to Glassdoor.com.

What is it like being a Research Nurse?

• Research Nurses provide and coordinate clinical care. Research Nurses have a central role in ensuring participant safety, maintaining informed consent, the integrity of protocol implementation, and the accuracy of data collection and data recording.

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How to Become a Research Nurse

4 min read • April, 28 2023

Are you looking for a new challenge in your nursing career? Whether you're just starting out or you're an experienced nurse, there are many nursing career paths from which to choose. Neonatal or dialysis nursing, for example, let you expand your knowledge within a specific discipline. Clinical research nursing, on the other hand, offers the opportunity to help conduct clinical trials for developing and testing new treatments, medications, and procedures.

Becoming a nurse researcher can be incredibly satisfying if you want to enhance your medical knowledge, expand therapeutic options for patients, and enjoy face-to-face care.

What Does a Research Nurse Do?

Clinical research nurses are on the front lines of medical innovation, helping research teams test the latest treatments and procedures. The role of a research nurse may vary daily depending on specific studies or trials in which you're participating. You can generally expect a mix of patient care, academic reporting, and record maintenance.

Some studies call for higher levels of patient interaction. You may interview patients before a new procedure or monitor, record, and report their progress after they've received an experimental treatment. Research nurses must often supervise patients to ensure they follow the study protocols correctly.

Besides patient interactions, a clinical research nurse may be responsible for writing reports or study results, submitting and publishing studies in medical journals, or presenting research findings at a medical conference.

What Studies Do Clinical Research Nurses Participate In?

Medical research is either quantitative or qualitative. As a clinical research nurse, you may participate in both. Quantitative studies focus on results that can be empirically measured, such as statistics. Qualitative studies, like case studies, are more holistic and help you better understand a question or issue from all angles.

Most clinical research is quantitative. For instance, a quantitative study of a new surgical procedure might measure how many days it takes a patient to recover compared to the previous method. Qualitative research, on the other hand, might focus on better understanding how cultural norms in a particular population affect their decision to get vaccines.

What Experience and Education Are Required?

The role of a research nurse isn't an entry-level position and typically requires extensive studies, which may include job-specific courses and additional nursing certifications. Due to the time involved in becoming a nurse researcher, you usually won't find many nursing professionals in this role early on in their careers. If you're interested in pursuing a position as a clinical nurse researcher, it's wise to start planning in advance.

Besides your licensure as a registered nurse (RN), you may want an advanced nursing degree such as a Master of Science in Nursing (MSN) or Doctor of Nursing Practice (DNP). Not every research nursing job will require an advanced degree. However, some employers prefer them, so having one can make it easier to get work.

Advanced degrees typically require a Bachelor of Science in Nursing (BSN) as a prerequisite. If you plan to get one, you'll need to take a longer path to get an RN degree or go back to school for your BSN before pursuing the necessary degrees for clinical research nursing. Some programs offer an accelerated program that combines BSN and MSN degrees.

Depending on your position or employer, you may also need specialized training in clinical research methodology and a certification from the Association of Clinical Research Professionals . To obtain a certificate, you must demonstrate as many as 3,000 hours (the equivalent of eighteen months of full-time work) of relevant work in human subject research within the last ten years. If you meet that requirement, you'll also need to take an exam before receiving your clinical research nurse certification.

How Long Does It Take to Become a Nurse Researcher?

Becoming a clinical research nurse can take ten years or more, depending on how much education and work experience you decide to pursue before applying for your first research position. If you intend to maximize your education and subsequent hiring possibilities, this comprehensive timeline outlines the steps you might consider:

• Years 1–4: Obtain a BSN degree, typically issued as a standard four-year degree.
• Year 4: Get licensed by taking the NCLEX-RN exam for registered nurses.
• (Optional) Years 5–7: Obtain an MSN degree. This program typically takes up to three years to complete.
• (Optional) Years 5–9: Obtain a Doctor of Philosophy in Nursing (Ph.D.) degree, which can take three to five years to complete.
• 2+ years of work experience: Whether you go directly from your BSN to your MSN or work in the field before pursuing an advanced degree, you'll likely need to spend time working as a nurse before you can apply for a clinical research position. If seeking certification, you'll also need relevant work hours in human subject research, which can take several years to accrue.

Clinical Research Nurse Salary and Career Prospects

The demand and salary for clinical research nurses are strong. Nurses, in general, are in high demand, and an increasingly technological health care industry always needs nurses to develop new treatments and procedures. The salary for a clinical research nurse is higher than the average for RNs, and these specialists make around $90–100,000 per year on average.

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Research Nurse

What is a Research Nurse?

Research nurses conduct scientific research into various aspects of health, including illnesses, treatment plans, pharmaceuticals and healthcare methods, with the ultimate goals of improving healthcare services and patient outcomes. Also known as nurse researchers, research nurses design and implement scientific studies, analyze data and report their findings to other nurses, doctors and medical researchers. A career path that requires an advanced degree and additional training in research methodology and tools, research nurses play a critical role in developing new, potentially life-saving medical treatments and practices.

How to Become a Research Nurse

A highly specialized career path, becoming a nurse researcher requires an advanced degree and training in informatics and research methodology and tools. Often, research nurses enter the field as research assistants or clinical research coordinators. The first step for these individuals, or for any aspiring advanced practice nurse, is to earn a Bachelor of Science in Nursing (BSN) degree from an accredited nursing school and pass the NCLEX-RN exam. Once a nurse has completed their degree and attained an RN license , the next step in becoming a research nurse is to complete a Master's of Science in Nursing (MSN) program focusing on research and writing. MSN-level courses best prepare nurses for a career in research, and usually include coursework in statistics, research for evidence-based practice, design and coordination of clinical trials, and advanced research methodology.

A typical job posting for a research nurse position would likely include the following qualifications, among others specific to the type of employer and location:

• MSN degree and valid RN license
• Experience conducting clinical research, including enrolling patients in research studies, implementing research protocol and presenting findings
• Excellent attention to detail required in collecting and analyzing data
• Strong written and verbal communication skills for interacting with patients and reporting research findings
• Experience in grant writing a plus

What Are the Schooling Requirements for Research Nurses?

The majority of nurse researchers have an advanced nursing degree, usually an MSN and occasionally a Ph.D. in Nursing . In addition to earning an RN license, research nurses need to obtain specialized training in informatics, data collection, scientific research and research equipment as well as experience writing grant proposals, research reports and scholarly articles. Earning a PhD is optional for most positions as a research nurse, but might be required to conduct certain types of research.

Are Any Certifications or Credentials Needed?

Aside from a higher nursing degree, such as an MSN or Ph.D. in Nursing, and an active RN license, additional certifications are often not required for work as a research nurse. However, some nurse researcher positions prefer candidates who have earned the Certified Clinical Research Professional (CCRP) certification offered by the Society for Clinical Research Associates . In order to be eligible for this certification, candidates must have a minimum of two years' experience working in clinical research. The Association of Clinical Research Professionals also offers several certifications in clinical research, including the Clinical Research Associate Certification, the Clinical Research Coordinator Certification, and the Association of Clinical Research Professionals – Certified Professional Credential. These certifications have varying eligibility requirements but generally include a number of hours of professional experience in clinical research and an active RN license. Here’s a breakdown of the various certifications you can get as a research nurse:

What Does a Research Nurse Do?

A research nurse studies various aspects of the healthcare industry with the ultimate goal of improving patient outcomes. Nurse researchers have specialized knowledge of informatics, scientific research, and data collection and analysis, in addition to their standard nursing training and RN license. Nurse researchers often design their own studies, secure funding, implement their research, and collect and analyze their findings. They may also assist in the recruitment of study participants and provide direct patient care for participants while conducting their research. Once a research project has been completed, nurse researchers report their findings to other nurses, doctors, and medical researchers through written articles, research reports, and/or industry speaking opportunities.

Where Do Research Nurses Work?

Nurse researchers work in a variety of settings, including:

• Medical research organizations
• Research laboratories
• Universities
• Pharmaceutical companies

What Are the Roles and Duties of a Research Nurse?

• Design and implement research studies
• Observe patient care of treatment or procedures, and collect and analyze data, including managing databases
• Report findings of their research, which may include presenting findings at industry conferences, meetings, or other speaking engagements
• Write grant applications to secure funding for studies
• Publish articles and research reports in nursing or medical professional journals or other publications
• Assist in the recruitment of participants for studies and provide direct patient care for participants

Research Nurse Salary & Employment

The Society of Clinical Research Associates reported a median salary for research nurses of $72,009 in their SoCRA 2015 Salary Survey , one of the highest-paying nursing specializations in the field. Salary levels for nurse researchers can vary based on the type of employer, geographic location and the nurse's education and experience level. Healthcare research is a growing field, so the career outlook is bright for RNs interested in pursuing an advanced degree and a career in research. Here’s a full range of salaries you can expect as a research nurse, according to ZipRecruiter.

Helpful Organizations, Societies, and Agencies

• National Institute of Nursing Research
• Council for the Advancement of Nursing Science
• International Association of Clinical Research Nurses
• Nurse Researcher Magazine

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• How Do I Become a Clinical Trials Research Nurse?

Steps to Becoming a Clinical Trials Research Nurse - Education & Experience

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Clinical research is the process of using science to better determine powerful and inventive means of detecting, diagnosing, treating, and preventing diseases and conditions. Clinical trials research nurses help outline trial criteria, write SOPs, evaluate research methods for efficacy, assist MDs or nurse practitioners with live procedures related to their studies, and deepen our collective medical understanding.

The international research community thrives on clinical research nursing. Research nurses are typically responsible for obtaining participants’ consent and recruiting, educating, and monitoring them. Additionally, these professionals report to the lead physician or NP and often coordinate the direct administration and evaluation of those treatments.

Some organizations use the term “clinical trials research nurse,” and others use the abbreviation “CRN.” Due to confusion concerning acronyms, most professional organizations use the former. Regardless of how you identify the position, no one can deny that as the Baby Boomers age, greater resources will be required to study the wide variety of medical problems that this generation faces.

Clinical research nurses maintain the quality, integrity, and honesty of clinical trials in both the public and private sectors, ensuring they comply with local, state, federal, and international regulations. They are often responsible for monitoring and checking in with study participants, completing test procedure paperwork, and structuring follow-up practices. These professionals develop and implement innovative solutions with numerous applications for the betterment of humankind and tackle some of our longest-running questions about human health. As students, prospective clinical trials research nurses study the components of nursing research, nursing theory, and how to evaluate the validity of the research properly.

Keep reading to learn how to become a clinical trials research nurse. Concentrating one’s studies on research nursing means joining the ranks of a small but significant quadrant of the research community.

Step-by-Step Guide to Becoming a Clinical Trials Research Nurse

Step 1 – graduate from high school.

Before graduating from high school, there are many ways that students can prepare for a career as a research nurse in clinical trials. It is recommended that to help prepare for coursework in clinical nursing and research, one should take a wide variety of courses in anatomy, physiology, mathematics, geometry, algebra, chemistry, physics, speech, and psychology. As admission to nursing programs is highly competitive, students are advised to pursue advanced placement coursework and set a goal of maintaining as high a grade point average as possible.

Another way to gain insight into the medical field is to intern at an extended care facility, nursing home, clinic, or teaching hospital. Volunteering, too, can be an excellent way to gain new perspectives on health, care, and nursing theory.

Step 2a – Graduate From an Accredited Nursing Program with an ADN (Two Years, Optional)

An associate’s degree in nursing (ADN) lays a clinical research and theoretical foundation for the work that one will undertake. Introductory coursework in anatomy, physiology, biology, nursing theory, and many more establish a skillset that blends the technical, technological, and medical.

Upon completion of two-year coursework, students will have received one of the following degrees: associate of nursing (AN), an associate of science in nursing (ASN), an associate degree in nursing (ADN), or an associate of applied science in nursing (AASN). Any of these degrees can prepare you to qualify for the NCLEX-RN exam.

Herzing University

The ASN program at Herzing University offers an accelerated, fast-paced course of study for those students wishing to achieve brisk entry into the industry. Students can complete this program in 20 to 24 months, depending on whether they have any transfer credits. General education courses are offered online, while core classes require on-campus attendance.

Made up of 70 to 73 credits, the program includes courses such as fundamentals of nursing; adult nursing systems; therapeutic use of self; pharmacology; nursing process and documentation; nursing management; mental health nursing; family nursing; and medical-surgical nursing.

• Location: Akron, OH; Birmingham, AL; Nashville, TN; Orlando, FL; Tampa, FL
• Accreditation: Higher Learning Commission (HLC)
• Expected Time to Completion: 20 to 24 months
• Estimated Tuition: $695 per credit

Step 2b – Graduate from a Nursing Program With a Bachelor of Science in Nursing (Four Years)

A BSN might be the best path for those interested in diving deeper into clinical trials research nursing. These courses of study build on the basics learned in an associate’s program, focusing on upper-level classes on research theory, nursing practice, and human resource management. At this stage, some aspiring CRNs seek concentrations focusing on clinical trials or research.

Schools such as the University of Michigan and the University of Washington boast top-notch BSN programs.

University of Michigan

The University of Michigan’s bachelor of science program in nursing provides students with a rigorous yet rewarding education filled with unique opportunities that will prepare them to become nurses and thrive as leaders in the field.

Comprising 128 credits, the program includes courses such as the culture of health; pathophysiology; reproductive health; behavioral health; health assessment; human anatomy and physiology; applied statistics; care of the family: infants, children, and adolescents; role transition; and leadership for professional practice.

• Location: Ann Arbor, MI
• Expected Time to Completion: Four years
• Estimated Tuition: Michigan resident ($1,046 to $1,133 per credit); non-resident ($2,654 to $2,815 per credit)

University of Washington

The University of Washington offers a bachelor of science in nursing (BSN) program preparing students for careers as registered nurses. Students in this program will learn from nationally acclaimed faculty members using interactive scenarios. They will learn to practice nursing skills in safe environments before performing them in supervised clinical settings.

Under the guidance of licensed care providers, students in this program will gain more than 1,000 hours of hands-on patient care experience. Students start in this program as college-level juniors after having already completed 60 semester-credits or 90 quarter-credits at the college level or a previous bachelor’s degree in a non-nursing field.

The curriculum includes courses such as foundational skills for professional nurses; foundations of professional nursing practice; foundations in pharmacotherapeutics and pathophysiology; fundamentals of nursing practice for illness care; health equity; healthcare systems and policy; ambulatory care; psychosocial nursing in health and illness; child health; and care coordination and case management.

• Location: Seattle, WA
• Accreditation: Commission on Collegiate Nursing Education (CCNE); Higher Learning Commission (HLC)
• Expected Time to Completion: Two years
• Estimated Tuition: Resident ($4,081 quarterly); non-resident ($13,580 quarterly)

Step 3a – Become Licensed as a Registered Nurse (Timeline Varies)

Each state requires that that state’s respective licensing channels must license those intending to become nurses. This directory collates data on how and where to obtain nursing licensing in all 50 states. Some states require a notarized personal statement or letter of intent with application paperwork.

The NCLEX-RN exam is the American testing standard for all registered nurses. After applying for the exam and offering proof of educational credentials, and meeting all state-specific criteria, nascent nurses must schedule an appointment to take the exam.

Administered by nursing professionals in closed exam rooms on isolated terminals, the exam uses machine learning to adapt its questions to the subject, specialization, and skill set. In some states, all of this work (including the exam) can be completed before a student’s official graduation date. This helps to expedite a nurse’s transition from student to practicing professional. Check state, institution, and employer policies before deciding on this approach.

Additionally, many certificates in clinical research, nursing science, and nursing research can be obtained online and added to one’s credential portfolio. For example, the University of Pittsburgh’s School of Nursing offers a certificate in nursing informatics .

Step 4 – Gain One Year of Clinical Trials Research Experience (One to Two Years, Optional)

Work experience in clinical trials can be critical to obtaining a clinical trials research nurse job. Many employers expect applicants to have already worked in this field. There are numerous ways to gain the necessary work experience, including working in administrative roles in trials, completing an internship, or working as a nursing assistant.

Step 5– Graduate from a Nursing Program with a Master of Science in Nursing (Two to Three Years, Preferred/Optional)

While much less common in customer and public care, advanced degrees in nursing are critical for those who wish to find a place in the leadership of clinical trials and research nursing .

Expanding on the foundations laid in a nursing BS program, an MS with a concentration in clinical research sciences often takes two or three years. Coursework covers clinical research theory, nursing theory, practicums in various healthcare and research environments, research development and coordination, clinical trial management, experiment design, and evidence-based practice, among other subjects. An MS in clinical research nursing positions students to transition into careers as research leads and assistants in pharmaceuticals, consumer products, clinical pathology, virology, oncology, and the study of infectious diseases.

Aside from nursing programs, there are also excellent master’s in clinical research degrees that nurses can complete to gain the necessary education to enter this field.

George Washington University

For example, George Washington University’s online MSHS in clinical and translational research is an excellent option for those looking to continue their education online. For a more traditional pathway, GW also hosts an on-campus clinical and translational research program that has been widely lauded.

The online MSHS program explores clinical administration, biomedical science, health policy, and community health. Graduates learn to develop best practices for bringing the latest medical science findings to the patients. This online program has no residency requirement.

The program’s 36-credit curriculum includes courses such as critical analysis of clinical research; clinical investigation; foundations in clinical and translational research; grantsmanship in translational health science; bioinformatics for genomics; biostatistics for clinical and translational research; and epidemiology translational research, among others.

• Location: Washington, DC
• Accreditation: Middle States Commission on Higher Education (MSCHE)
• Estimated Tuition: $1,315 per credit

Step 6 – Graduate with a Doctoral Degree in Nursing or a Clinical Research Discipline (Four to Seven Years, Optional)

There are two doctoral nursing degrees available, both of which are terminal, meaning that no further paths of education are available to those who hold these degrees. While a doctor of nursing practice (DNP) is a clinical practice degree intended for advanced nurse practitioners, a PhD in clinical research and trials nursing requires pursuing and studying an area of expertise that results in a doctoral dissertation and its defense.

Some advanced nursing programs will accept a BSN as a satisfactory degree when students apply for graduate school. However, the industry standard is to obtain an MSN before entering advanced postgraduate nursing studies. Always remember to contact an institution’s admissions office and check in to their criteria for application.

William Carey University

William Carey University offers a cutting-edge PhD in nursing science. This doctor of philosophy program in nursing education is a terminal degree that prepares DNP graduates to serve as nurse educators and nurse scholars. Except for four weekend meetings per year, this program can be completed entirely online and is a convenient option for full-time working students.

The curriculum includes courses such as role development for the nurse educator; curriculum development and program planning; instructional strategies and evaluation of student learning; creating an online educational environment; advanced curriculum assessment and evaluation; research development; advanced research methodology; and program evaluation.

Applicants to the program must hold a DNP from an accredited school of nursing, a GPA of 3.0, a current unencumbered nursing license, and submit three reference forms, among other requirements.

• Location: Hattiesburg, MS
• Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
• Estimated Tuition: $610 per trimester hour

Texas Woman’s University

Texas Woman’s University boasts two doctoral nursing programs: one in nursing science and one allowing students who have already obtained a DNP to extend their education and gain a clinical PhD. These programs can be completed either online at the Denton campus or in a hybrid format at the Houston campus.

In the nursing science PhD program, students receive the investigative aptitude, management skills, and advanced nursing knowledge needed to earn a spot at the healthcare leadership table, whether at hospitals, classrooms, or clinical settings. Admission requirements to this program include a current unencumbered U.S. RN license, a bachelor’s or master’s degree in nursing from a nationally accredited program, and a minimum GPA of 3.0.

The PhD in nursing science program requires completion of 60 credits beyond the master’s and includes courses such as philosophy of nursing science; ethical dimensions of nursing; exploring scientific literature; measurement and instrumentation in nursing research; qualitative nursing research; theory for nursing research and practice; quantitative nursing research; and determinants of health.

The DNP-to-PhD bridge program requires the completion of 42 credits. Applicants to this program must have a current unencumbered U.S. RN license, show evidence of graduation from a DNP program offered by a regionally-accredited university with national certification in nursing preferred, and have a minimum GPA of 3.5.

• Location: Denton, TX
• Expected Time to Completion: Two to four years
• Estimated Tuition: $7,140 per semester

University of Central Florida

For those seeking an online degree, the University of Central Florida offers a nursing PhD that has built a web-based curriculum around two on-campus intensives each year. This online PhD prepares graduates for careers at the forefront of nursing science, where they will be contributing to the body of knowledge and leading research in the application of innovative strategies for nursing education and clinical care.

The program requires the completion of 63 credits beyond the master’s degree. Those without an MSN degree should pursue the BSN-to-PhD in nursing program. The BSN-to-PhD program requires the completion of 72 credits beyond a bachelor’s degree.

• Location: Orlando, FL
• Expected Time to Completion: 11 to 15 semesters
• Estimated Tuition: In-state ($288.16 per credit); out-of-state ($1,073.31 per credit)

Step 7 – Obtain Certification Through the Association of Clinical Research Professionals (Timelines Vary, Optional)

Certification through the Association of Clinical Research Professionals (ACRP) demonstrates to employers that the candidate has achieved a high level of competency in clinical research education and training. Clinical trials research nurses can earn two primary certifications: a Certified Clinical Research Associate (CCRA) or a Certified Clinical Research Coordinator (CCRC).

The eligibility requirements for either certificate are the same. Candidates must have 3,000 hours of work experience in the six content areas of clinical research trials. A formal education program may substitute for up to 1,500 hours of work experience.

The content of the exams is similar and includes scientific concepts and research design, ethical and participant safety considerations, product development and regulation, clinical trial operations (GCPSs), study and site management, and data management and informatics. While the exam topics are similar, the CCRC exam is more in-depth and covers more advanced material than the CCRA.

Helpful Resources for Clinical Trials Research Nurses

Many valuable resources are available for prospective research nurses, from non-profits to representative organizations to job boards. Below are some of the most useful resources for those wishing to pursue a career pathway as a clinical trials research nurse:

• Association of Clinical Research Professionals
• Center for Information & Study on Clinical Research Participation
• Clinical Trial Resources (ASCO)
• Council for the Advancement of Nursing Science
• Global Research Nurses
• National Institute of Nursing Research
• NCLEX Registered Nurse Practice Test Questions
• Oncology Nursing Society’s FAQs
• Society of Clinical Research Associates
• Eastern Nursing Research Society (ENRS)
• The Midwest Nursing Research Society (MNRS)
• Southern Nursing Research Society (SNRS)
• The International Association of Clinical Research Nurses (IACRN)

Kimmy Gustafson

With a unique knack for simplifying complex health concepts, Kimmy Gustafson has become a trusted voice in the healthcare realm, especially on MHAOnline.com, where she has contributed insightful and informative content for prospective and current MHA students since 2019. She frequently interviews experts to provide insights on topics such as collaborative skills for healthcare administrators and sexism and gender-related prejudice in healthcare.

Kimmy has been a freelance writer for more than a decade, writing hundreds of articles on a wide variety of topics such as startups, nonprofits, healthcare, kiteboarding, the outdoors, and higher education. She is passionate about seeing the world and has traveled to over 27 countries. She holds a bachelor’s degree in journalism from the University of Oregon. When not working, she can be found outdoors, parenting, kiteboarding, or cooking.

Related Programs

• 1 Online MSN/MBA Dual Degree Programs – Nursing & Business
• 2 Online Master’s Degrees in Food Safety – Regulatory Affairs & Quality Assurance
• 3 Online Master’s in Clinical Nurse Leadership (CNL)
• 4 Online Master’s in Nurse Administration – MSN Degree Nurse Administrator
• 5 Online Master’s in Nurse Education (MSN Degree)
• 6 Online Master’s in Nurse Informatics (MSN Degree)
• 7 Online Master’s in Clinical Research Administration Programs

Related FAQs

• 1 Are There Online Nursing Administration Programs That Do Not Require the GRE?
• 2 Clinical Significance vs. Statistical Significance
• 3 How Do I Become a Nurse Administrator?
• 4 How Do You Become a Clinical Research Coordinator (CRC)?
• 5 What Can I Do With a Master’s Degree (MSN) in Nurse Administration?
• 6 What Can You Do with a Degree in Biotechnology?
• 7 What Can You Do with a Degree in Clinical Research Administration?
• 8 What is Clinical Data Management (CDM)?
• 9 What is Nursing Administration?
• 10 What is a Clinical Application Analyst and What Do They Do?

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Clinical research nursing and factors influencing success: a qualitative study describing the interplay between individual and organisational leadership influences and their impact on the delivery of clinical research in healthcare

Linda tinkler.

Trust Lead, Nursing, Midwifery and AHP Research, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK

Lisa Robinson

Consultant Allied Health Professional, Major Trauma Rehabillitation Department, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Newcastle upon Tyne, UK

Clinical research delivery is a term increasingly used to describe the work undertaken to implement studies which explore and test prevention, diagnosis and treatment in healthcare. Such studies range from multi-site clinical trials to single site observational projects. Whilst widely acknowledged as fundamental to effective healthcare, clinical research is complex to deliver and is met with challenges in the busy clinical environment. The perceptions and experiences of Clinical Research Nurses, whose work is central to this agenda, have emerged as important, yet frequently overlooked insights in relation to the potential success of research delivery. Increased understanding of these insights is essential to address the barriers and maximise facilitators to success in clinical research.

To better understand how the perceptions and experiences of Clinical Research Nurses relate to potential for success in research delivery.

Seven focus groups and two one-to-one interviews (27 participants) were conducted in a large tertiary North East England National Health Service Foundation Trust between March and June 2017.

Clinical Research Nurses’ described perceptions and experiences of working to co-ordinate and deliver a range of research as individuals, within their teams, throughout the wider organisation, and beyond. Two key elements situated within an overarching theme of leadership emerged as likely to impact on how successfully they were able to practise:

• the individual (self-leadership).

• the organisation (leadership culture).

Conclusions

The framework emerging from this study illustrates a complex interplay between personal attributes and organisational culture, mediated by national strategies and targets associated with the clinical research agenda. When situated within the concept of leadership, it broadens the potential for understanding the underlying issues and increases the range of possible support mechanisms to improve experiences for Clinical Research Nurses. Framing the challenges in this way contributes new knowledge to the dialogue surrounding clinical research delivery.

Introduction

The successful delivery of clinical research is fundamental to enabling continuous improvements in health ( Cooksey, 2006 ; Department of Health, 2017 ). Research-active organisations report better patient outcomes and research activity and engagement at all organisational levels is fundamental to high-quality care provision. The Care Quality Commission (CQC) now enables NHS organisations to showcase research engagement as part of its inspection programme ( CQC, 2017 ; Ozdemir, 2015 ).

Trial recruitment challenges are relevant to the entire healthcare community and increasingly cited in the literature ( Adams et al., 2015 ; Donovan et al., 2014a , b , 2016 ; Elliot et al., 2017 ). The Clinical Research Nurse (CRNurse) workforce is a key element of successful research delivery and an integral part of the research journey for patients. The perceptions and experiences of their role and the content and context of their work are emerging as an important marker in understanding the complexities of trial delivery ( Adams et al., 2015 ; Gibbs and Lowton, 2012 ; Hamer, 2017 ; Hill, 2018; Jones, 2017 ; Kunhunny and Salmon, 2017 ; MacArthur et al., 2014; Tinkler et al., 2018 ; Whitehouse and Smith, 2018 ).

Previous research from our team explored the role and the ethical perceptions of Clinical Research Nurses (CRNurses) specifically in relation to their roles, undertaking study recruitment and the informed consent process ( Tinkler et al., 2018 ). The findings emerging from that study identified numerous factors that could adversely impact on successful research delivery. Factors included a range of intrinsic and extrinsic issues, such as role transition and the conflict between core clinical values and perceived pressure to recruit. Altered relationships with multidisciplinary colleagues and perceptions of how the CRNurses were viewed by the wider organisation led to reduced morale and contributed to staff turnover. Kunhunny and Salmon (2017) reported similar findings in relation to issues undermining the professional identity of CRNurses and role-related challenges. The work of Whitehouse and Smith (2018 ) has highlighted the need for clearer CRNurse strategies and structure, and further research into professional identity, understanding of the role by multi-professional team members and work to increase the evidence base regarding the role and impact.

The recent National Institute for Health Research (NIHR) CRNurse strategy has further highlighted the need for visible leaders in clinical research nursing along with the imperative to demonstrate the impact of the CRNurse in the patient journey. The International Association of Clinical Research Nurses (IACRN) embodies similar aims through their Scope and Standards of Practice ( American Nurses Association and International Association of Clinical Research Nursing, 2016 ). As such clinical research nursing is recognised as specialty nursing practice by the American Nurses Association, though this status is not the case in the UK.

With increasing interest and expertise emerging in this area, there is an opportunity to influence policy and practice in relation to the CRNurse role, whilst contributing to the dialogue on trial recruitment challenges through a focus on self-leadership and organisational culture ( Jones, 2017 ; Whitehouse and Smith, 2018 ).

Methodology

A qualitative study design used focus groups as the primary method of data collection. Focus groups maximise the benefit of group interaction and generate data that highlight underlying factors influencing the feelings, attitudes and behaviour of participants ( Kitzinger, 2006 ; Krueger and Casey, 2015 ). Focus groups were also chosen due to their time effectiveness for busy clinical staff. One-to-one interviews were added approximately one month into data collection in response to requests from potential participants. The lead author (LT) adopted a constructivist approach, facilitating participants to share their experiences, focusing on enablers and barriers to their practice as CRNurses, in a supportive, confidential environment ( Mills and Birks, 2014 ).

Sample/participants

The host organisation for this study is one of the largest NHS foundation trusts in the UK, with a sustained successful track record in clinical research delivery; 108 CRNurses were employed by the organisation at the time of study recruitment. These individuals were invited to participate, via email of the participant information sheet (PIS) from team leaders. The email invited potential participants to opt in by returning an expression of interest form via email to LT. The email stated that involvement was voluntary and that a decision not to take part would not affect subsequent interactions or relationships with the researcher or the organisation. Participants were given up to four weeks to decide on participation and were free to ask questions prior to making a decision. LT attended organisational meetings to present the study and its background, however participants were not known to LT prior to study commencement.

Data collection

Data were collected during the working week between March and June 2017. Focus groups were conducted at one hospital site, utilising two dedicated meeting rooms situated away from the clinical area to reduce interruptions. One-to-one interviews were conducted at a venue of the participants’ choice in the workplace. Each focus group comprised of between two and seven participants and lasted approximately two hours. Interviews lasted approximately one hour and 30 minutes. All interviews and focus groups were digitally audio-recorded with participants’ consent and transcribed verbatim by an independent transcriber approved by the study sponsor. LT, an adult nurse qualified to Masters’ Level, with 14 years’ clinical experience, (nine of these in designated research roles) moderated all focus groups and interviews. Open-ended questioning was supported by a topic guide ( Table 1 ).

Topic guide.

Data analysis

Data were analysed systematically by LT using an inductive approach which incorporated thematic analysis ( Braun and Clarke, 2006 ) supported by NVivo 11 qualitative data analysis software. Thematic analysis enabled an iterative process of engagement with the data through familiarisation by repeatedly listening to recordings and comparing with transcripts, generating initial codes and organizing data excerpts within NVivo, searching for and identifying themes, reviewing, defining and naming themes, before producing the final report.

Although they did not emerge as a useful strategy for increasing participation, the semi-structured interviews confirmed the themes generated by the focus groups and proved to be a valuable source of data triangulation ( Carter et al., 2014 ).

A high level of consensus was reached by the third focus group. Although data saturation may have occurred, data collection continued until everyone who had expressed an interest in participating had been given the opportunity to share their views. No new themes emerged in the subsequent data collection.

LT’s experience as a CRNurse and her developing knowledge and expertise in this area has contributed to the development of concepts, subsequently informing the study design and conduct. These experiences have stimulated a strong commitment to objectively exploring the subject and have subsequently fostered a level of trust and credibility with participants, meaning they were comfortable with LT’s motivations as a researcher. Data verification was sought from LR, via regular discussions throughout the data collection and analysis process.

A post-data-collection feedback workshop was undertaken to present results and provide opportunities for staff to discuss their implications and plan actions. This was well attended by original participants, other CRNurses who were unable to contribute to the original data collection and allied health professionals with an interest in the work. Outputs from the workshop confirmed the themes emerging were an accurate and relevant reflection of the content of sessions, and it emerged that they were also reflective of experiences of those who were not present at data collection, adding further validity to the themes.

Of the 108 staff invited, 47 responded to the initial email invitation: 27 went on to participate, through seven focus groups and two one-to-one interviews. Non-participation resulted from work pressures, sickness, annual leave, leaving post or conflicting patient visits. Focus groups and interviews comprised of CRNurses working in a variety of practice settings across the organisation, from ward-like clinical research units to independent specialty teams operating out of offices.

The framework presented in Figure 1 illustrates the complex interplay between personal attributes, organisational culture, national priorities and strategic direction in clinical research delivery. Preliminary data analysis generated over 80 initial ‘nodes’ within NVivo. These were refined, combined and eventually translated into two overarching themes and seven sub-themes:

• 1. The individual:
•   1.1. prior experience and personal attributes;
•   1.2. the patient;
•   1.3. the role.
• 2. The organisation
•   2.1. communication;
•   2.2. feeding the machine;
•   2.3. structure and teams;
•   2.4. the reality.

Theoretical framework.

These themes and subthemes form the basis of our presentation of the qualitative findings. We will demonstrate how a focus on leadership at an individual and organisational level has the potential to enhance our understanding of the experiences of the CRNurse, shifting the emphasis towards the development of support strategies to overcome the challenges associated with clinical research delivery.

The individual

Experiences of the CRNurse role are impacted by the individual in the post. Intrinsic individual factors may explain why some CRNurses react differently to others with the challenges and complexity of the role.

I think for some people, their personality is better to deal with that [negativity from other staff] in research … other staff might not be as resilient to put up with things like that. It’s another stress in the day isn’t it I suppose … (IP2)

Prior experience and personal attributes

The importance of ‘know-how’ was debated. Narratives varied depending on whether participants had prior experiences of delivering research or knowledge of the CRNurse role. Prior knowledge of the specialty, or familiarity with staff in that area made a difference.

it probably makes the job a little bit easier initially if you know a little of the terminology about the specialty. Maybe know some of the doctors, or some of the team already. (P6FG1)

It was agreed that experience of delivering research is hard to come by and this is often the main element of know-how in the role that needs to be developed for the new CRNurse. However, if the CRNurse is coming into post as a research novice and also picking up an unfamiliar clinical specialty, this is particularly challenging. One participant (P3FG7) described this as ‘coming in with two hands [tied] behind your back’.

There was a lack of uniformity in the approach to inductions across the teams. As this became apparent it led to various debates with mixed views about what was important and how it should be developed. This suggests role transition and induction is critically important.

I have been in this post a year and have only just got to feel like I’m starting to get a handle on it. There’s still lots I don’t know … (P1FG7)

Despite the challenges described, participants recognised the value of their role and were keen to express the positive elements that they feel are little known.

And actually, it’s a privilege isn’t it, and I didn’t realise, the privilege, and actually, these patients want to be here … I enjoy coming to work so much more … I didn’t think that would have been as big a thing to me. I just thought it would be a job, I feel if people knew this, more people would want to work in research. (P7 FG1)

The patient

The nurse–patient relationship was a prominent and positive element of individual narratives, providing them with familiarity with previous nursing roles, as well as a close holistic nurse-patient relationship.

You feel you are doing something good towards improving nursing and treatments for patients which is why a lot of patients seem to want to be on studies and I think that it feels good to be able to contribute to that. (IP2)

CRNurses consistently described themselves as advocates for patients. Although this sometimes led to conflict with medical PIs, they expressed a clear vision of their role and positive contribution to the patient pathway. They described knowing instinctively when it was or was not appropriate to approach patients. Experiences of receiving informed consent and conducting research in areas where there were little or no other treatment options left were discussed. Whilst posing challenges around timing, appropriateness of approach and patient priorities during difficult times, CRNs felt offering hope through research participation was important.

Maybe it’s like a, you know that gut feeling isn’t it. It’s hard to describe … We’ve had patients that have signed up for an early phase study and yes, they understood the information and signed the consent form but talking to them, I was like, this patient doesn’t want to do this study. And then I had to go back to the consultant and say, this is just not sitting right with me … (P1FG5)

Some CRNurses described a reduction in patient contact resulting from moving into a research post, however this was not the case in every area.

I personally don’t have as much contact with patients and people have found that quite challenging and they still want to keep their hand in and in some studies you do, you have a lot of contact but some you don’t, and I think that is probably one of the biggest things you have to find out straightaway that you are not going to be over bothered by the amount of contact that you have with patients. (P3FG5)

CRNurses described the positives of having time to spend with patients. They sympathised with their non-research counterparts expressing how limited quality time with patients can be in areas outside of research.

I think that is the main thing that I get from the job, especially the older population, I love just going and chatting to them. Having the time, whereas normally when I’m on the ward you can’t because there’s either a buzzer or someone wants tablets, there is always something going on. (P4FG5)

The range of ways CRNurses deal with the role as individuals depends on numerous factors. This impacts on experiences, thoughts, mind-set, job satisfaction and intention to remain in post. The consensus was that the CRNurse should feel positive about the specialty they are practising in and the job itself should be intrinsically motivating. If this is not the case it can impact on morale and mind-set, ultimately affecting study delivery.

Factors such as the type of study, its design, sponsor and complexity were important and there was a mixture of opinions about the value of commercial versus academic research. Some participants preferred commercial studies:

I love commercial studies … I just feel it is a lot more professional, I feel they are run better, I feel like the protocols are more in depth, more detailed, I feel like academic protocols are rushed to a degree. I’m not saying that academic you know, there’s a place for it. But as a nurse, when I get an academic study, I’m like oh, nightmare. (P7FG1)

Others preferred academic work, and expressed frustration at aspects of commercial trial delivery:

I think commercially … when they’re writing them, they have no idea what happens in clinical practice … I think generally they don’t consider that there’s clinical things going on, everything just has to be done, they’re very narrow-thinkers. (P4FG1)

Individual capacity and capability were debated, along with the challenges of measuring workload, intensity, and when to decline studies. There was agreement that what one person may find challenging and exciting, another may find stressful and overwhelming. The support received in day-to-day practice varied, and a feeling of responsibility and lack of ability to hand over caused tension for some. Some individuals valued the autonomy and associated ownership of their studies, including a sense of achievement in delivering it successfully.

That’s what I found really difficult coming to the role. Knowing that there wasn’t another shift coming after me … knowing that there is not another team coming on after, you know, and having to get everything organised weeks in advance, like really forward planning for your patients. I found that really difficult. And managing my own time is, difficult. (P1FG5)

There was a passion for attracting others into CRNurse roles, and participants debated how to inspire others to consider trying research nursing. There was an appetite to raise awareness of the role with other nurses to help them understand the role. Offering student placements was particularly positive for those who had the opportunity to do so, recognising the value of the opportunity to inspire the next generation.

it’s about being quite outgoing and upfront about what you are doing and talking to people and just getting integrated … I think, you know, they’re introducing students into research I think that might help as well. (P4FG1)

The organisation

There was an understanding that healthcare is complex, with numerous priorities and strategies that CRNurse teams and individuals contribute to. In research these can sometimes feel more complex because of the increased number of external stakeholders, and the link to other national priorities.

Communication

Communication discussions focused on dialogue between the CRNurse and the Medical PI.

I think some of them do it because they maybe feel they should do be doing it, rather than actually being enthusiastic about it. The consultant we are talking about, I don’t know why they chose the two studies because they’re not interested in them really. It is almost like a pain. You are a nuisance, to ask them to sign this, or see the patient. (P1FG4)

Communication was discussed in relation to the individual teams, external study teams and the wider organisation.

I tried to go to one of those specialist nurse groups and I felt absolutely out of place. And I thought, well I shouldn’t, because we should be here but I did feel I didn’t belong there really … I don’t know I think I was probably the only CRNurse. (P1FG4)

Internal meetings and the tone of communication was raised by the majority of participants.

It’s about perspective, we can come out of a meeting and feel that we’ve been absolutely flogged because we are not meeting targets, but then you look and we are at the top … It’s not reflected in the culture, it’s just ‘duf duf duf’ [gestures towards pressure]. (P1FG6)

Feeding the machine

One message that was clearly identified throughout the study was around funding and targets. ‘Feeding the machine’ was a poignant description to make sense of the challenges the CRNurse workforce experiences, with messages of reduced funding and the pressure to deliver every study successfully to time and target.

It is, it’s all about targets isn’t it – meeting targets and if you don’t then heaven help you. (P2FG6)

Concerns around job security were shared. These were identified as a new feeling in comparison to working on a ward, as discussions about funding repeatedly linked patient recruitment to funding for posts.

But you also get told well numbers are jobs. So, we need to keep our accruals up or we lose funding and then that will be somebody leaving. You know, you do get told that. (P1FG4)

Despite such observations, some teams admitted to enjoying, even thriving on a little healthy competition.

I must admit, I think I am a little bit target driven. I quite enjoy it to an extent actually … they are not such a bad thing because there is something to aim for … (P1FG6)

Structure and teams

Structure and team working impacted on experiences. Working across specialties was described as less positive than a focused approach. Participants acknowledged that this was necessary to enable effective delivery of the wide range of studies across different clinical areas in the context of a limited research delivery workforce. They also recognised the resulting opportunities to enhance skills development and the potential to support colleagues in other teams, though this approach to working introduced competing priorities.

You were just trying to spread yourself too thinly … you were working with different PI’s who wanted to see patients on the same day at the same time and you couldn’t … (P1FG3)

Those working in areas with limited contact with their clinical counterparts felt isolated, describing the challenges of motivating teams to support their roles.

So I think we are a product of our own success in that we have managed to successfully separate research and deliver research in parallel to the clinical service, but it’s not embedded in the clinical service because you’ve got a whole separate research department and so the clinical staff can now think oh no that’s for the research department … (P1FG6)

Those who were more embedded clinically either through where they were based geographically or through their specific role, reported more positive experiences.

I prefer and I would suggest the reason I get so much out of my job is because I feel part of the directorate, the clinical directorate … I like being part of that … (IP)

The reality

The reality of operating within the organisation varied across the teams and individuals. Visibility and awareness of the role outside of research was linked with communication, structures and teams, and it also linked back to individual attributes.

I think a lot of people don’t know what we do and don’t understand that all the current drives that research should be an option for all patients and that it’s actually good for patients and it can benefit them … I think they don’t realise that being nicer to us and allowing us to get access to the patients would actually be them supporting their patients … (IP)

Access to space and facilities varied across the teams.

I mean one of the pressures we have at the minute is that we do not have a designated area to see our patients so we go down to out-patients and you are not stressing about whether the patient’s going to go in [the study] or not you are stressing about whether you are going to have a room. (P1FG3)

Others described a feeling of isolation in terms of where they were based geographically, and a struggle to be accepted into the clinical areas they needed to access to be able to undertake their patient visits.

We are the last in the pecking order of who needs to see. When I am waiting to see somebody in clinic … the dietician is free now so they will just pinch them. So I will wait, and they will come out of the dietician and the psychologist is waiting … and then before you know it you’ve been waiting there an hour to see somebody, and they want to go then because they’ve been there for that long [laughs]. Because there was nowhere for you to go and you always felt the clinical need to go and see somebody was greater than yours. (P3FG5)

There was talk of emotional labour, making an extra effort to be welcomed into the area or allowed space to practise.

I’ve gone back to being a second class citizen in the Trust, so I feel that quite a lot, I feel like I have to justify what I do. (P6FG1)

There were excellent examples of work going on to raise awareness and visibility of the CRNurse contribution to the patient pathway. Posters, information boards, staff presentations, research champions and linking in with multi-disciplinary meetings were described. These activities and the impact of them weren’t shared widely, and those attending the focus groups seemed to learn from the experience, taking practical strategies away with them to try.

On each ward there’s somebody allocated, and they will come to a meeting so many times a year where we tell them a little bit about research, about things we have to do and a bit about the studies that again is relevant to their ward … There’s posters on every ward, again it’s a directorate thing, they want very much to integrate research and the directorate stuff … (P4FG1)

The findings illustrated above indicate a complex blend of factors with the potential to impact on successful research delivery. These factors arise from a combination of interplay between the personal attributes of CRNurses, their experiences and behaviours and how they are impacted by and can equally impact on organisational culture and national priorities. This combination of factors and a focus on self-leadership and organisational culture has the potential to contribute to the dialogue on challenges in clinical research delivery and should be considered by policy makers and organisational leads.

The King’s Fund (2011) acknowledges high levels of complexity and debate related to the many definitions of leadership and its impact.

Historically, leadership has been described and interpreted in a positive manner:

Leadership is interpersonal influence, exercised in a situation, and directed, through the communication process, toward the attainment of a specified goal or goals ( Tannenbaum et al., 1961 ).

In its most basic form, however, leadership is derived from individual approaches to influencing, in order to modify the behaviours of others towards a specific goal, agenda or outcome. Zalenik (1992) captures the essence of leadership as follows:

Leadership requires using power to influence the thoughts and actions of other people.

An increased focus on leadership in recent years, has led to improved awareness of how individual behaviours can impact on performance and experiences, ultimately translating into the quality of outcomes, whether for individual consumers or businesses as a whole ( Blanchard, 2010 ; Goleman, 2013 ; Kouzes and Posner, 2012 ; Sinek, 2014 ; Yukl, 2013 ).

The findings from the present study describe intrinsic feelings, perceptions and motivators that have the potential to impact on actions and reactions to events, pressures and expectations placed on individuals to varying degrees. These intrinsic factors are often described through psychological trait theory, which is reported to influence how we act in addition to situational factors such as learned behaviours, lived experiences and social interactions. This results in what is described as self-leadership ( Goleman, 2013 ; Northouse, 2013 ).

Trait theory historically indicates that the majority of intrinsic characteristics are relatively fixed, with limited scope for development; however, behavioural research has increasingly identified that individuals have the capacity for development and change through increased self-awareness ( Northouse, 2013 ). Increased self-awareness, understanding the relevance of prior experiences and knowledge, in addition to greater awareness of the CRNurse role prior to being appointed, could assist in recruitment and selection for posts, improve experiences of role transition and enhance performance within the role.

The suggestion that some nurses are more suited to research delivery posts than others and the individual nature of how one person’s ability to ‘cope’ with the complexities of the role differ to another, relate to the concept of resilience. This is the subject of increasing debate in healthcare at present. Whilst implementing strategies to enhance personal resilience may assist individuals in dealing with the challenges they face, the very concept of resilience is argued to foster a submissive mindset, placing responsibility for coping with adversity in the hands of the individual rather than enabling action to explore the core of the issues and identify what support is required ( Traynor, 2017 , 2018 ).

Intrinsic issues are also associated with professional identity; a broad term emerging from our previous study, described as a continuing process of development affected by numerous social interactions and environmental factors ( Franco and Tavares, 2013 ; Workman and Pickard, 2008 ). A positive professional identity is fundamental to performance, impacting on patient care, job satisfaction and decisions to remain in a particular post ( Cowin et al., 2008 ; Kunhunny and Salmon, 2017 ). Professional identity in clinical research nursing is under-researched, and the results of this study suggest a positive, embedded organisational research culture, is a key mediator of a positive professional identity.

The experiences described by participants in relation to organisational challenges, indicate an increasing level of discomfort with the current target-based culture in research delivery, and whilst CRNurses were able to articulate the relevance of targets, they were negatively impacted by the focus on funding linked to those targets. This left them feeling there was limited focus on improved patient outcomes and the value and benefit of research participation for patients.

The Nuffield Trust (2015 ) identified funding crises, NHS management and culture, and the effectiveness of performance targets as priorities for the Government to address. Re-connecting with the core NHS workforce to improve engagement and empowerment, and implementing successful workforce development and planning, were also key priorities, however, growing workloads and staff shortages underline the current pressure on the NHS workforce, impacting staff morale ( The King’s Fund, 2017 ).

Whilst the research arena has historically been less affected by funding crises, the issues described above are increasingly evident, and equally important, and the majority of participants acknowledged this. Difficulties meeting trial recruitment targets, combined with the threat of funding reductions based on reduced activity, may have affected the morale of CRNurses ( Tinkler et al., 2018 ). Reduced morale across the NHS may also have potentially contributed to disconnection between CRNurse teams and their wider organisational colleagues.

Organisational and team-focused research predominates the healthcare leadership literature, with a focus on collective and multilevel models to define the most effective approaches to leadership (Yukl, 2013; MacPhee et al., 2013 ). Increased performance and safer care are synonymous with satisfied and contented teams and a recent shift in leadership culture within the NHS has identified increasingly that a top-down approach results in disengaged staff, ultimately leading to poorer standards of care ( The King’s Fund, 2011 , 2012 ; Turnbull James, 2011 ; West, 2012 ). Turnbull James (2011) also identified that it is vital to engage and empower staff to recognise the importance of their unique contribution in the provision of high-quality care. This is as important in research delivery as any other sphere of healthcare delivery.

Healthcare priorities are driven by various national and government strategies influencing and directing every element of practice. The NIHR was established in the UK through one such government strategy ( Department of Health, 2006 ). The seven high-level objectives (HLOs) from the NIHR influence practice and performance in research delivery in the UK. The general tone of these HLOs is about increasing numbers of patients into studies and reducing the time taken to achieve this. The core foundations of these high-level objectives are with patients in mind, in being able to prevent ill health, improve diagnosis and offer better treatments more readily ( NHS England, 2014 , 2016 ). Funding is also a key foundation of the HLOs aimed at improving the UK’s reputation as a setting for research ( Department of Health, 2017 ; NHS England, 2013 ). As identified by the participants in this study, the tone of the message from national strategies and how those messages are translated into practice have the potential to affect organisational culture, which mediates individual experiences as professionals operating at the frontline.

‘The NHS Long Term Plan’, launched in January of 2019 articulates the clear necessity for change in the health service, including a commitment to release pressure at the frontline whilst capitalising on the medical advances we currently benefit from. The plan commits to increased funding to support staff whilst continuing to sustain and further develop a vibrant life sciences sector ( NHS England, 2019a ).

The subsequent launch of ‘The NHS Interim People Plan’ built on the commitments of this through dedicating a strategy to improving the leadership culture, tackling the nursing workforce challenges we currently see and making the NHS the best place to work ( NHS England, 2019b ). By harnessing the recommendations in this plan there is scope to further influence the Clinical Research Nursing agenda through improving awareness and attitudes towards research, whilst working to address some of the unhelpful behaviours that have impacted on relationships, experiences and productivity in the research area.

The framework and results presented in this paper provide a valuable contribution to the evidence base in this under-represented area, with the potential to influence policy and practice in relation to clinical research delivery. It highlights the numerous factors that have the potential to impact on the practice of CRNurses and introduces how they may subsequently affect how well research is delivered. Themes emerging from this piece of work build on previous work and confirm that there is transferability between areas of practice and types of organisation.

A focus on self-leadership and organisational culture, whilst positioning the discussion within the context of the wider health service and national priorities provides a context for the issues described and shifts dialogue towards increased focus on approaches to communication, awareness, visibility and support mechanisms to inform policy and practice and overcome challenges associated with clinical research delivery.

The challenges described also suggest there is further engagement work to do to improve understanding of the importance of the CRNurse role in the patient pathway. Within its recently launched CRNurse strategy (2017–20), clear recognition of CRNurses, and their unique role in the delivery of quality clinical research care was identified as key to achieving the NIHR mission. Increasing the understanding of the experiences and perceptions of the CRNurse is essential to address the barriers to research delivery and increase awareness and understanding of the role of the CRNurse and associated challenges.

The following key points have been generated from this study:

• This study contributes to the increasing literature indicating that work to deliver research in the clinical environment is complex and that CRNursing roles are often poorly understood outside of research delivery teams
• Exploring the experiences and perceptions of CRNurses is increasingly highlighting important and inherently complex factors related to successful research delivery. This approach should be further developed to fully understand the issues and influence policy in relation to organisation of the workforce
• This study adds new knowledge in relation to the finding that research delivery relies on a complex, multi-faceted range of factors originating from individual clinical research nurses and the organisations in which they operate. This is mediated by the context of national drivers and strategies influencing their work and this should be considered in relation to the wider NHS workforce
• The concept of leadership is a useful frame in which to situate the challenges associated with clinical research delivery. This has the potential to facilitate a broader dialogue on the subject and increases the potential for developing appropriate support mechanisms to address the barriers, whilst maximising the facilitators to clinical research delivery

Limitations

Although data were collected in a single organisation the findings were consistent with previous and other emerging research.

It became apparent during the recruitment process that the agreed approach to sampling staff had not been followed by all team leads. Some expressed discomfort with the email approach and therefore did not send emails to their teams. Instead they made Participant Information Leaflets available to staff through placing them at the nurses’ station. At this time, it is not possible to say with certainty whether all CRNurses were given the opportunity to participate, or whether they felt able to do so confidentially, due to this unforeseen change to the sampling process.

Key points for policy, practice and/or research

• Consideration should be given to the relevance of strategies to increase personal resilience and consider where these may assist in addressing the challenges identified.
• Work should be undertaken to improve the induction process and more broadly improve the organisational support offered to CRNurses in the delivery of their roles.
• The utility of the target-based culture in the NHS should be explored further, more specifically in relation to where this may be impacting on clinical research delivery roles.
• Further exploration of the utility of the NIHR HLOs should be considered, including how they may be adapted to reduce the focus on recruitment to time and target and include metrics measuring the impact of research, dissemination and knowledge transfer and real impact on health inequalities and unwarranted variations in care.
• The interface between the CRNurse role and their multiprofessional colleagues from the perspective of those colleagues could be investigated to enable enhanced understanding of their needs in relation to supporting the delivery of research and the opportunities for patients in their care to participate in research.

Acknowledgements

The lead author would like to thank Aileen Burn, Matron for Clinical Research Delivery at Newcastle upon Tyne Hospitals NHS Foundation Trust.

Linda Tinkler is the Trust Lead for Nursing, Midwifery and Allied Health Professionals Research at Newcastle upon Tyne Hospitals NHS Foundation Trust. Linda's role involves leading and implementing research specific strategies, policies and initiatives on behalf of the Executive Chief Nurse team. This includes building research capacity and capability to enable staff in the NMAHP disciplines to develop along the research continuum from research awareness to research leadership. Linda's own research interests include leadership culture in the NHS and the interface between Clinical Research Delivery and Clinical Practice. She is currently undertaking a PhD through a Royal College of Nursing Strategic Research Alliance with the University of Sheffield, is a Florence Nightingale Leadership Scholar and an NIHR 70@70 Senior Nurse Research Leader.

Lisa Robinson is currently employed as Consultant Allied Health Professional – Major Trauma Rehabilitation. Her clinical and research interests are informed by four key areas: improving healthcare organization and delivery; improving patient experience and outcomes; advancing complex interventions research methods in a rehabilitation setting; and workforce development and professional learning in the nursing, midwifery and allied health professions, with a particular emphasis on building research capacity and capability.

Contributor Information

Linda Tinkler, Trust Lead, Nursing, Midwifery and AHP Research, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.

Lisa Robinson, Consultant Allied Health Professional, Major Trauma Rehabillitation Department, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Newcastle upon Tyne, UK.

Declaration of conflicting interest

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The study was assessed and approved through the UK Health Research Authority (HRA: 17/HRA/0125), and capacity and capability to participate was confirmed by the sponsor/host organisation. The study did not require full Research Ethics Committee approval due to the involvement of NHS staff members only. Participants provided written informed consent prior to data collection.

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Study funding was awarded to the lead author through a competitive process by Newcastle upon Tyne Hospitals NHS Foundation Trust, utilising NIHR Research Capability Funding (Ref. No. 1617-039).

Linda Tinkler https://orcid.org/0000-0003-3052-0640

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Nursing at the NIH Clinical Center

Clinical research nurse roles.

Medical Support Assistant: The Medical Support Assistant (MSA) performs administrative duties to support the medical staff, nursing staff and patients, as well as other Clinical Center Departments and Institutes. They are responsible for coordinating and organizing patients' administrative and clerical information utilizing the hospital information systems. They facilitate patient visits, coordinate administrative work, and serve as the focal point for communications within the clinic/unit.

Program Support Assistant: The Program Support Assistant (PSA) provides direct administrative, procedural, and informational resource assistance and support to program staff and/or managers by organizing, collecting, analyzing, and presenting information related to the current and future program/project workload. Assists with the coordination of program workflow and the coordination of various duties assigned to program staff.

Program Specialist: The Program Specialist (PS) supports the administrative functions of the operations of the area assigned including financial management, procurement, quality assurance, management analysis and timekeeping. They participate with senior specialists in the coordination, preparation, and analysis of a wide variety of reports.

Staff Assistant: The Staff Assistant directs and implements administrative functions for the assigned office. Keeps the supervisor fully informed of current conditions throughout the department and takes appropriate action to ensure that administrative activities are properly implemented to support its mission. Maintains liaison and coordination between the department and other offices in the Clinical Center and the NIH. Establishes and implements standards for the efficient operation of the office and coordinates with other staff within the office and department, ensuring that administrative and clerical functions result in smooth operations.

Health Technician, Phlebotomist: The Health Technician Phlebotomist provides clinical care and supports biomedical research under the supervision of a licensed nurse. The incumbent supports a team that provides collection of blood and blood components from donors/patients by either collection of a unit of whole blood or blood components utilizing apheresis. The incumbent performs venipuncture on donors/patients within the Blood Services Section for allogeneic use or for in vitro studies carried out by the various Institutes at the NIH.

Health Technician, Surgical: Provides technical support and patient care support for both major and minor surgical procedures. These duties include assistance with positioning the patient and surgical prep. Patient care also involves the transport of patients to and from the surgical suite, as well as assisting staff during surgical procedures as directed.

Medical Instrument Technician (Surgical): The Medical Instrument Technician (Surgical) assists with surgeries under the supervision of surgeons, registered nurses, or other surgical personnel. They help set up the operating room, prepare and transport patients for surgery, adjust lights and equipment, pass instruments and other supplies to surgeons and surgeon's assistants, hold retractors, and help count sponges, needles, supplies, and instruments.

Patient Care Technician: The Patient Care Technician supports the activities of the professional nurse by independently providing patient care functions to assigned patients while maintaining a safe environment.

Behavioral Health Technician: The Behavioral Health Technician supports the activities of the professional nurse by independently providing patient care functions to assigned behavioral health patients while maintaining a safe and therapeutic environment.

Healthcare Simulator Technician: The Healthcare Simulator Technician assists the Simulation Program Coordinator/Nurse Coordinator by providing simulation operational expertise and clerical support for the NIH Clinical Center Simulation Program.

Diagnostic Radiologic Technologist (Interventional Radiology): The Diagnostic Radiologic Technologist in Interventional Radiology (IR) is trained in radiographic imaging guided procedures and has the professional skills/expertise required to integrate interventional procedures/exams into overall clinical management. This position is a key part of the IR team performing procedures/exams on patients and actively participates in the design, implementation and evaluation of new imaging methods and techniques utilized in this area.

Lead Diagnostic Radiology Technician: The Lead Diagnostic Radiology Technician functions as the team leader for the team of diagnostic radiology technicians performing interventional radiology services. As the team leader they utilize a variety of coordinating, coaching, facilitating, consensus-building, and planning techniques.

Program Manager for Sterile Processing Service: The Program Manager for the Sterile Processing Service manages the Sterile Processing Service which is the central point that all contaminated supplies, equipment, and materials are sent after use. It includes sterile and non-sterile storage, and centralized decontamination, high-level disinfection, and sterilization. It supplies equipment to the operating rooms, laboratories, inpatient areas and specialty clinics, and dispatch areas for distribution to approximately 60 supply issue points throughout the NIH Clinical Center complex.

Lead Medical Supply Technician (Sterile Processing): The Lead Medical Supply Technician for Sterile Processing functions as the team leader for the team of medical supply technicians (sterile processing) on an assigned shift and personally performs the work of medical supply technicians (sterile processing). As the team leader, they utilize a variety of coordinating, coaching, facilitating, consensus-building, and planning techniques.

Medical Supply Technicians (Sterile Processing): The Medical Supply Technician is responsible for the decontamination, packaging, sterilization, high level disinfection and distribution of medical/surgical instruments and equipment in the Clinical Center.

Clinical Research Nurse 1: The Clinical Research Nurse (CRN) 1 has a nursing degree from a professional nursing program approved by the legally designated state accrediting agency. The CRN 1 is a newly graduated registered nurse with one year or less of clinical nursing experience. The incumbent functions under the direction of an experienced nurse to provide patient care, while using professional judgment and sound decision making.

Clinical Research Nurse 2: The Clinical Research Nurse (CRN) 2 has a nursing degree or diploma from a professional nursing program approved by the legally designated state accrediting agency and has practiced nursing for at least one year. This nurse independently provides nursing care; identifies and communicates the impact of the research process on patient care; adjusts interventions based on findings; and reports issues/variances promptly to the research team. The CRN 2 administers research interventions; collects patient data according to protocol specifications; evaluates the patient response to therapy; and integrates evidence-based practice into nursing practice. The CRN 2 contributes to teams, workgroups and the nursing shared governance process. New skills and knowledge are acquired that are based on self-assessment, feedback from peers and supervisors, and changing clinical practice requirements.

Clinical Research Nurse 3: The Clinical Research Nurse (CRN) 3 has a nursing degree or diploma from a professional nursing program approved by the legally designated state accrediting agency at the time the program was completed by the applicant. The CRN 3 has practiced nursing for at least two years. The role spans the professional nursing development from “fully competent” to “expert” nursing practice. The CRN 3 provides care to acute and complex patient populations and utilizes appropriate professional judgment and critical decision making in planning and providing care. They master all nursing skills and associated technology for a particular Program of Care and assists in assessing the competency of less experienced nurses. The CRN 3 participates in the planning of new protocol implementation on the patient care unit; administers research interventions; collects patient data according to protocol specifications; evaluates the patient’ response to therapy; responds to variances in protocol implementation; reports variances to the research team; integrates evidence-based practice into nursing practice; and evaluates patient outcomes. The CRN 3 assumes the charge nurse and preceptor roles as assigned. Formal and informal feedback is provided by the CRN 3 to peers and colleagues in support of individual growth and improvement of the work environment.

Clinical Research Nurse 4: The Clinical Research Nurse (CRN) 4 has a nursing degree or diploma from a professional nursing program approved by the legally designated state accrediting agency at the time the program was completed by the applicant. The CRN 4 is a clinical expert and leader in all aspects of nursing practice. They demonstrate expertise in the nursing process; professional judgment and decision making; planning and providing nursing care; and knowledge of the biomedical research process. The CRN 4 utilizes basic leadership principles and has an ongoing process of questioning and evaluating nursing practice.

Supplemental Nurse/Float Pool/Per Diem: Supplemental Staff are Temporary Intermittent RN positions within the Nursing Department that are assigned to either a Central Pool or are Unit Based. Central Pool Supplemental staff work out of the Office of Staffing and Workforce Planning, select their schedule based on the available needs of the house and are assigned as needed to different units. Unit Based Supplemental staff are assigned to a unit and select their schedule to meet the unit’s needs. If not needed on the unit for their scheduled shift, they can be floated like any other member of the unit nursing staff. Float to all units as assigned within their competency skill set as needed.

Clinical Manager/Team Lead: The Clinical Manager (CM)/Team Lead is an experienced staff nurse who supports the Nurse Manager and other departmental leadership with operations and leadership of a patient care area(s). This position functions as a team leader and it utilizes a variety of coordinating, coaching, facilitating, consensus-building, and planning techniques to lead a team of Clinical Research Nurses and paraprofessionals. They provide patient care, as well as support protocol implementation, data collection and human subject protection.

Clinical Educator: The Clinical Educator (CE) is an experienced staff nurse who provides direct patient care and collaborates with the Nurse Manager and other departmental leadership to oversee educational needs of unit staff. The CE develops/coordinates/evaluates orientation for new unit staff, trains/mentor’s unit preceptors, serves as a liaison/resource for departmental/Clinical Center/professional educational opportunities, identifies educational needs, coordinates unit in-services, and plans unit educational days. The CE designs, implements and evaluates learning experiences for all staff levels to acquire, maintain, or increase their knowledge and competence. The Clinical Educator teaches at the unit and departmental level.

Safety & Quality Nurse: The Safety and Quality Nurse provides direct patient care and coordinates, oversees and evaluates the quality improvement and patient safety initiatives at the unit or program of care level. They collaborate with the nurse manager and department leaders on improvement activities related to promoting patient safety, clinical quality and reducing risk. They develop and maintains proficiency in effective use and interpretation of data to drive quality improvement activities on the unit or program of care level.

Program Director : The Program Director serves as the supervisor of a group of expert advisors for a specific area of nursing expertise (education, recruitment & outreach, safety & quality, staffing & workforce planning). The incumbent coordinates, implements, and oversees all the operations of the program they oversee. They serve as the liaison to other Clinical Center departments and the ICs for issues related area of expertise and assigned responsibility and to provide communication and consultative services to all credentialed nurses at the Clinical Center.

Nurse Manager : The Nurse Manager has 3 to 5 years of recent management experience; advanced preparation (Masters degree) is preferred. The Nurse Manager has experience in change management, creative leadership, and program development; an demonstrates strong communication and collaboration skills to foster an effective partnership with institute personnel. The Nurse Manager demonstrates a high level of knowledge in a particular specialty practice area and utilizes advanced leadership skills to meet organization goals.

Clinical Nurse Specialist : The Clinical Nurse Specialist (CNS) has a Masters or Doctorate Degree in Nursing from a state-approved school of nursing accredited by either the National League for Nursing Accrediting Commission (NLNAC) or the Commission on Collegiate Nursing Education (CCNE) with a major in the clinical nursing specialty to which the nurse is assigned. The CNS has a minimum of 5 years’ experience, is certified in a specialty area, and is accountable for a specific patient population within a specialized program of care.

Nurse Educators : The Nurse Educator plans, directs, executes, and evaluates a broad program of nursing professional and educational activities directed toward professional development of nursing and support staff. Designs, implements and evaluates learning experiences for all staff levels to acquire, maintain, or increase their knowledge and competence. Collaborates in the design and implementation of learning needs assessment tools for unit and specific programs of care.

Nurse Consultant: The Nurse Consultant serves as an expert advisor with responsibility for managing a broad array of administrative projects and providing clinical consultative support for a Clinical Center Nursing Department Service or program. The Nurse Consultant leads, or directs projects related to clinical research nursing, staffing, budgeting, policy, safety, and human resources.

Nurse Scientist: The Nurse Scientist is a nurse with advanced preparation (PhD or doctorate in nursing or related field) in research principles and methodology, who also has expert content knowledge in a specific clinical area. The primary focus of the role is to (1) provide leadership in the development, coordination and management of clinical research studies; (2) provide mentorship for nurses in research; (3) lead evaluation activities that improve outcomes for patients participating in research studies at the Clinical Center; and (4) contribute to the overall health sciences literature. The incumbent is expected to develop a portfolio of independent research that provides the vehicle for achieving these primary objectives.

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Clinical research nursing

A one-stop-shop for nurses working in clinical research

Clinical research nurses play a vital role in delivering clinical research, and ultimately improving patient care.

Clinical research is essential.

It is the only evidence-based method of deciding whether a new approach to treatment or care is better than the current standard, and is essential to diagnose, treat, prevent, and cure disease. Clinical research nurses play a vital role in delivering clinical research, and ultimately improving patient care and treatment pathways.

Duties could include:

• supporting a patient through their treatment as part of a clinical trial
• preparing trial protocols and other trial-related documentation
• helping to develop new drugs, treatments, care pathways or regimens for patients
• dealing with data collection
• submitting study proposals for regulatory approval, and co-ordinating the initiation, management and completion of the research
• managing a team.

Celebrating clinical research nursing and its vital role in health care

29 April 2021, London

COVID-19 and clinical research nurses

The current pandemic has raised the awareness of clinical research and the impact it has on identifying effective treatments to treat this recently emerging virus. From the outset, clinical research has been a key part of the government's response and the plan to contain, delay, research and mitigate. Clinical research nurses (CRNs) have been key to the effective delivery of many of the COVID-19 interventional and observational studies now running or completed. In order to focus recruitment on key treatment studies, trusts have been encouraged to prioritise studies approved by the UK's four Chief Medical Officers (CMO) and running within the National Institute of Health Research (NIHR) Clinical Research Network.

The following articles provide further information on the work of CRNs during the current pandemic.

• Iles-Smith H et al on behalf of the Association of UK Lead Research Nurses (2020) How research nurses and midwives are supporting COVID-19 clinical trials . Nursing Times [online]; 116: 11, 20-22.
• Jones H et al (2020) Clinical research nurses and midwives - a key workforce in the coronavirus pandemic . Nursing Times [online]; 30 Apr 2020.

Clinical research and the NIHR

The National Institute for Health Research (NIHR) funds health and care research and provides the people, facilities, and technology that enables research to thrive.

The NIHR invests significantly in people, centres of excellence, collaborations, services and facilities to support health and care research in England. Collectively these form the NIHR infrastructure, which can support you to:

• find collaboration opportunities
• access methodology advice
• access facilities for early stage research
• run your study
• access data, patient cohorts or sample support

Collaborations, services and support for your research

Are you a nurse, midwife or allied health professional (AHP) practicing in the NHS? Do you have views about how research is delivered by Clinical Research Nurses in the NHS? Would you be prepared to share those views?

The Represent-CRN study is part of the Royal College of Nursing Strategic Research Alliance with the University of Sheffield. It aims to explore the views of registered NHS staff operating outside of clinical research delivery teams, in relation to the Clinical Research Nurse role and research delivery.

By exploring these views, we hope to shed light on what leads to different perceptions of research, ultimately to enable more patients to have the opportunity to participate in research that is relevant to their health.    Find out more about the study .

Looking for a career in clinical research?

If you work in the NHS, most Trusts have R&D departments, who will put you in touch with the lead clinical research nurse: there may be opportunities to shadow, or do short-term work placements.

• National directory of NHS research offices

Research nursing across the UK

National Institute for Health Research

• The role of the clinical research nurse

Health and Social Care R&D Division

• HSC Trust research offices
• Northern Ireland Clinical Trials Unit
• Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN)

Chief Scientist Office

• NHS Research Scotland (NRS)

Scottish Research Nurse and Co-ordinators Network

Health and Care Research Wales

• Clinical Trials Units

Organisational research structures and strategies

Publications which may help organisations to develop their own research infrastructure.

• Whitehouse, CL. And Smith, HA. (2018) The Whitehouse Report: Review of research nursing and midwifery structures, strategies and sharing of learning across the UK and Ireland in 2017. The Florence Nightingale Foundation .
• Jones, HC. (2017) Exploring the experience of Clinical Research Nurses working within acute NHS trusts and determining the most effective way to structure the workforce: A mixed methods study .

Further reading

A selection of articles about research nursing.

• Tinkler L. Smith V. Tuannakou Y and Robinson L. (2017) Professional Identity and the clinical research nurse: A qualitative study exploring issues having an impact on participant recruitment in research . Journal of Advanced Nursing
• Jones H.C. (2015) Clinical research nurse or nurse researcher? Nursing Times. 111(19) 12-14
• Hamer S. (2015) The nurse's changing role in clinical research . Nursing Times. 111(39) 12-14
• Gleason K (2013) What is a Research Nurse and what do they do? Clinfield Blog

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Clinical Research Professional Roles in Research

Clinical Research Professionals (CRPs) at Penn are integral members of the research team. The goal is to have highly trained, competent an motivated individuals in these roles. Some of their job functions include:

• Data Collection, Analysis, or Monitoring
• Case Management Of Protocol Participants
• Recruitment And Enrollment Of Human Subjects
• Protection of Subjects And Subjects’ Rights
• Development of Informed Consent Documents
• Preparation of Adverse Event Experience Reports
• Construction or Monitoring Of Case Report Forms
• Maintenance of Drug Accountability Records
• Development of Grants And Budgets
• Preparation of Reports
• Educating Other Healthcare Professionals, Patients or Families About Clinical Trials 
• Protocol Development
• Program Administration
• Auditing Research Program
• Regulatory document submissions and maintenance

Training of CRPs is largely competency based using the CTSA ( Clinical and Translational Science Awards ) Program followed by ACRP ( Association of Clinical Research Professionals ). The ACRP modules, depicted below, are supplemented with Penn specific content.

Clinical Research Operations

OVERVIEW: Clinical Operations refers to the activities that support the clinical trial process from start-up to close out. Clinical Operations professionals are tasked with the planning, implementation, management, and execution of the clinical trial process. This role includes clinical research assistants, clinical research coordinators and clinical research operations professionals.

TRAINING: for more information see Required Training section under Clinical Research Professionals .

Clinical Research Nursing

OVERVIEW: The specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. This specialty practice incorporates human subject protection; care coordination and continuity; contribution to clinical science; clinical practice; and study management throughout a variety of professional roles, practice settings, and clinical specialties ( International Association of Clinical Research Nurses. (2012) "Enhancing Clinical Research Quality and Safety Through Specialized Nursing Practice". Scope and Standards of Practice Committee Report)

Clinical Research Monitoring/ Quality

OVERVIEW: Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.  The clinical research monitor is the person with direct access to, and oversight, of the site research activities. They conduct monitoring visits in accordance with a monitoring plan and provide feedback and training to sites as necessary.   

Clinical Research Regulatory Affairs

OVERVIEW: A Regulatory Affairs specialist is responsible for knowing and operating within the legal framework established for clinical research and product development of drugs and devices.  This includes obtaining necessary approvals from local entities such as the IRB; and federal authorities such as the FDA to conduct research in humans. Regulatory Affairs also ensures essential documents are maintained and always inspection ready.  Skills of a Regulatory Affairs Specialists include a basic understanding of research, project management, preparing submissions, and effective communication.  

Clinical Research Data Management

OVERVIEW: This role manages research data, creation of datasets for investigators, performing data quality assurance checks, creation of new summary variables for analysis, and creation of data tables for reports and papers. This role provides general administrative support for research data, completion of data collection forms, extracting and entering required clinical data from medical records and patient research charts to Case Report Forms (eCRFs/CRFs). 

Clinical Research Project Management

OVERVIEW: This role oversees the operation and execution of all aspects of a clinical research study. Includes recruitment of participants and implementation of objectives for each study 

Clinical Research Training For Nurses: A Guide to Becoming a Clinical Research Nurse

Clinical research training for nurses, guide to becoming a clinical research nurse, what is clinical nursing research.

Nurses are known for providing direct care for patients. However, nurses may take up roles that are completely new to them within the world of clinical research. These roles include clinical research coordinator , educator and manager. They can also take up less traditional role like regulatory specialist, study monitor and IRB (institutional board review) admin.

Regulatory specialist: their activities relate mainly with preparing regulatory documents and communicating with regulatory bodies. Nurses can work as a regulatory affairs specialist, a regulatory operation coordinator, or a regulatory coordinator . They can work within government agencies, pharmaceutical companies, academic medical centers.

Study monitor: they monitor clinical research practices and make sure that it complies with necessary research protocols and regulations. They tend work at government agencies, biotechnology companies, pharmaceutical companies, contract research organizations, device manufacturers etc. Aspiring study monitors can enhance their qualifications with a Pharmacovigilance Certification .

Institutional Review Board (IRB) administrator: they are the professionals in charge of overseeing, administrating, implementing and managing IRB activities, like policies and procedures that relates to protecting human welfare. They can work at all IRBs: local, commercial or central IRB.

Nurses that have developed interest in the field of clinical research can join professional organizations. This provides them with the opportunity to network and continue their education through mediums like conferences, webinars, discussion groups, publications and online resources. These avenues serve as part of their clinical research training .

Certification is often a parameter used to measure professional expertise. This is based on criterion that reflects skill, knowledge, educational preparation, ability, and competence that are developed from experience in that area of specialization. Nurses that developed an interest in clinical research and have taken a clinical research training program have an opportunity to be certified through the:

Society for Clinical Research Professionals, Inc. (Certified Clinical Research Professionals)

Association for Clinical Research Professionals (Certified Clinical Research Associate or Certified Clinical Research Coordinator)

This field of clinical research gives nurses a chance, an opportunity to advance themselves professionally in a field that might not have been explored by them before. The benefits of having a registered nurse cover letter are insurmountable. This also provides a career path that can show family members the benefits of working in the medical field.

Nurses that have gone through the clinical research for nurses , otherwise called research nurse can carry out research on the various aspects of the human health, such as illness, pharmaceutical and health care methods and treatment plans. The main aim of this research is to improve the quality of health care service delivery. Helping patients and their family in a healthcare facility also brings a level of joy that is hard to find in many other career paths.

Roles of Research Nurses

They are responsible for designing and implementing research studies.

They observe procedures for treatment, collect and analyze data.

They report their research results to appropriate quarters.

They write articles and report their research findings in nursing or medical professional publications and journals.

They help in recruiting participants for studies and are involved in providing direct care for the participants.

Clinical research nurse salary can make use of their communication skills as well as their critical thinking skills gotten from their knowledge and experience in healthcare to further their career in this exciting way.

Know that future CRNs can speak to our 24/7 chat and phone advisors to request information on partial scholarships and payment plans for nurses.

2. Clinical Research Nurse Salary

The average pay for a Clinical Research Nurse is $31.28 per hour.

MD Anderson Cancer Center  Clinical Research Nurse salaries  - $71,503/yr

Northwestern University  Clinical Research Nurse salaries  - $75,005/yr

NIH  Clinical Research Nurse salaries  - $77,331/yr

CLINICAL RESEARCH NURSE JOB Description

A clinical research nurse conducts scientific research on different aspects of human health like illnesses, pharmaceuticals, treatment plans and healthcare methods. Their major goal is to improve the quality of healthcare services that are administered to the patients.

Source: Payscale

3. How do I get Clinical Research Nurse Experience?

Experience don’t just jump on you, you have to get it by practice. CCRPS affords you an opportunity to acquire knowledge in clinical research , and not just knowledge but experience as well. Registering for the appropriate course will boost your knowledge base and as well you get experience of clinical research first hand.

As a clinical research nurse, you will be at the forefront of new medical discoveries, and help develop breakthrough cures and medical treatments. The work that you do during your career can help some patients live longer or better quality of life. You may be responsible for studying diseases and disorders, as well as developing new treatment plans. You will also help test new treatments and medications that could possibly change the way a disease or disorder is perceived.

The field of clinical research can be very rewarding and fulfilling. A good research nurse is dedicated to their work and ready to take on everything that the profession throws their way. If you’re looking to pursue a research nursing career, you should have an excellent understanding of the research process as well as the specialty area that you’re studying.

Excellent communication skills are also a must. You must be able to effectively communicate with scientists, physicians, researchers, patients, and corporate executives.

4. What Does a Clinical Research Nurse Do?

The duties of a research nurse will typically depend on their employer and role. Some research nurses may be responsible for studying diseases, while others may help create and improve new medications and other treatments.

clinical research nursing scope and Standards of Practice

Clinical research nurses can take up clinical research jobs in institutions like research organizations, pharmaceutical companies, universities, research laboratories, government agencies and teaching hospitals.

The work that a research nurse does is quite exhaustive and it includes;

They use their knowledge of the basics of clinical research in designing and implementation of research studies.

Observation of the procedures for patient treatment, collection and analyzing of data.

They report their research findings to the relevant authorities. They may also have to present their results at health conferences and publish them in journals.

They write grant applications in order to secure funds to carry out the research.

They render assistance in the process of recruiting study subjects.

They provide direct treatment for research participants.

Research nurses that study diseases and illnesses will often perform a great deal of research, both by studying previous findings and observing patients. They may be required to examine medical journals, for instance, as well as observe, study, and care for patients suffering from a particular disease.

They make decisions based on the observations made as to which patients are the best candidates for certain clinical trials. During clinical trials , the research nurse will administer medications or perform other treatment procedures, During this process, research nurses must closely monitor each patient’s progress. This includes documenting side effects, drug interactions, and the overall efficiency of the medication.

Aside from caring for patients, documenting and recording information during clinical trials are the most important responsibility that a research nurse has. The information and data gathered during the research must be compiled into reports and handed over to senior clinical researchers or specialists.

5. How Do I Become a Research Nurse?

Don’t expect to become a research nurse overnight. It's a lot of work and you are expected to undergo years of training and experience.

The clinical research nurse job is a competitive one and certificates are not just handed out to anybody. The conditions to be eligible to take the certificate exam is that you must be an experienced registered nurse and your experience must include having thousands of hours of experience in the area of clinical research.

How to Become a Registered Nurse (RN) in 2020 that contains everything a person pursuing a nursing job should know - responsibilities, education, salaries and more.

The first step toward becoming a research nurse is to obtain a proper education. You can start with a bachelor’s degree in nursing, although many employers prefer that their research nurses have master’s degrees or even doctoral degrees in their chosen specialty. During your schooling, classes in research and statistics are a must and are courses in your chosen area of expertise.

According to clinical research job websites , many research nurses have a MSN degree and some have a PhD in nursing. Many of them attain these degrees of education in order to give them an edge on getting clinical research positions . While studying, courses in statistics and research are mandatory.

There are two main certifications that clinical research nurses can get from the Association of Clinical Research Professionals (ACRP). You can get certification to become a certified clinical research associate or you can choose to become a certified clinical research coordinator.

Take courses from CCRPS and learn more on how to become a clinical research nurse.

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course

6. Clinical Research Nurse Requirements and Certifications & Nursing Cover Letter

A bachelor's degree in nursing does meet licensure requirements for graduates to become registered nurses (RNs), which qualifies individuals for the specialized certification. Bridge programs, such as an RN-to-Bachelor of Science in Nursing (BSN), require previous nursing education for admission. Nursing students complete traditional classroom courses, laboratory experiences, and a clinical practicum in a medical setting, which includes a hospital, assisted living facility, and long term care center.

For specific education in clinical research , trained RNs enroll in graduate certificate and degree programs. There students are introduced to case studies, ethical research practices, and financial matters affecting the design, implementation, and funding of clinical research trials. In a master's program, studies in research ethics point students towards ethical research practices, including a discussion on human rights, misconduct, and conflicts of interest. Graduate programs will also include quantitative research and a capstone project.

All RN-to-BSN programs will require an RN license to enroll. Master's and graduate certificates will need a bachelor's degree with sufficient prerequisite coursework in the field. In addition, they will need letters of recommendation or reference, a personal statement, and GRE scores.

Becoming a nurse researcher which is a highly specialized career requires an advanced degree and training in informatics and research methodology and tools. The initial step for these individuals, or for any aspiring advanced practice nurse, is to earn a Bachelor of Science in Nursing degree and pass the NCLEX-RN exam. Once a nurse has completed their degree and attained an RN license, the next step is to complete a Master's of Science (MSN) in Nursing program with a focus on research and writing. MSN courses prepare nurses for a career in research and usually include coursework in statistics, research for evidence-based practice, design and coordination of clinical trials , and advanced research methodology.

A TYPICAL JOB POSTING FOR A RESEARCH NURSE POSITION WOULD LIKELY INCLUDE THE FOLLOWING QUALIFICATIONS, AMONG OTHERS SPECIFIC TO THE TYPE OF EMPLOYER AND LOCATION:

MSN degree and valid RN license.

Experience conducting clinical research, including enrolling patients in research studies, Implementing research protocol and presenting findings.

Excellent attention to detail required in collecting and analyzing data.

Strong written and verbal communication skills for interacting with patients and reporting research findings.

For a person to practice nursing legally, acquiring of nursing credentials and certifications is very important. For instance, some nurses who achieve a master's degree (MSN) leave the patient care aspect of nursing, and practice in a more managerial role.

CRA JOB OPPORTUNITIES

If you choose to become a Clinical Research Associate (CRA), you will have a key role in the success of clinical trials. Most CRAs have a nursing background, like yours. You will be the primary contact and support for trial sites, ensuring that the study is conducted according to the protocol, ICH-GCP, regulatory requirements and standard operating procedures (SOPs).

The Clinical Research Associates also offers you the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them.

Take courses from CCRPS and learn more on how to become a clinical research professional.

Speak to our 24/7 chat and phone advisors to request information on partial scholarships and payment plans for nurses.

About CCRPS

How much is a clinical research coordinator’s salary.

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The Role of the Clinical Research Nurse

Published: 17 May 2019

Version: 1.0 - June 2019

Clinical Research Nurses: In their own words

We spoke to nurses about their experience of working in this exciting space and the variety of roles our clinical research nurses undertake. All speak of having started their research careers with an uninformed view of what a research role could bring them.

All speak of their surprise at the autonomy of the role, the skills they have developed and the variety of work they undertake. All speak of working in great teams, the career opportunities that have opened for them and the importance of their relationships with the clinical research nursing community.

All speak of the challenges they have faced and overcome in research. And all speak of their passion for research. Most importantly they all speak of their crucial role in delivering high quality patient care. 

Here are their stories, in their own words.

Building Local Research

Anne Suttling, Senior Research Nurse, Portsmouth Hospitals Trust

After qualifying as a nurse, I commenced a rotation programme for 18 months. I worked in surgery, medicine, Accident and Emergency, critical care and also coronary care – where I gained a permanent post. That’s where my love is in coronary care and cardiology.

After seven years, I needed a change but still wanted to remain in cardiology. That’s when the opportunity to set up a research study came up. On the first day I was faced with an empty six – bedded bay, on an empty ward and told this was the available space to set up the clinic. The study was a success and on the back of this, the PI got funding for a full – time research nurse, to run interventional studies.

I remember the first complex commercial portfolio study I set up. Before I recruited my first patient I did not sleep the night before. I took home the packaging for all the bloods and biomarkers and had it all out in my living room … there was so much to get my head around. It did go ok – we became one of the top UK recruiters for the study. Because research in the department was working well, more PIs wanted to come on board. They could see research wasn’t such a demanding workload for them because research nurses were organising what they had to do and carrying out the study management.

I currently manage 17 staff in eight specialities. This brings its own challenges. A ward manager has one speciality on their ward and can see what is happening. In this role, you can’t be in renal, gastro and surgery if problems arise. So it’s slightly more difficult to manage. But I am learning so much about other specialities. I enjoy the patient contact and the patients really enjoy being in research. Patients have a hotline to consultants and any problems or issues they call the research nurse.

Our role is so diverse – it is not just recruiting patients. 

I go to monthly meetings with the industry manager. If a company want 8 sites in the UK, they will send out expression of interest forms. If they get 20 back, they will do site selection visits. We also get selected for commercial studies off the back of our success in recruiting to other studies … you start to build up a name for yourself. We also get selected for commercial studies off the back of our success in recruiting to other studies. You start to build up a name for yourself.

A clinical research nurse has a certain amount of autonomy. You have to be able to manage your own time, prioritise and pay attention to detail. Data queries can drive you insane, but that is what research is about. It is all recruit, recruit, but, what is the point if the data is not correct? Part of being a research nurse is having the determination to meet targets. Follow ups don’t necessarily count (as part of the target). You are under pressure to recruit but you still have to follow-up patients … that is what I find difficult. You are perceived to be successful if your recruitment figures are high. Follow up and maintaining consent throughout the trial is just as important – this is when the majority of data is collected.

Our role is so diverse – it is not just recruiting patients. There are follow-ups, collecting data for the CRFs, maintaining site files, knowing about the agencies, regulatory bodies, protocols, consent and giving presentations to inform colleagues about what we do in research.

Cardiology were nominated in 3 or 4 categories at the Portsmouth Hospitals Research Conference and won a “Research Merit Award”. This was in recognition of how we built up cardiology research over the last three years. In cardiology we are getting more PIs on board because they can see we are organised. The PIs are understanding that they don’t have to do all the work. They have a team of experienced research nurses to co-ordinate their trials.

Change Research Cultures

Alison Mortimer, Lead Nurse, NIHR Clinical Research Facility, Sheffield

I fell into research. I bumped into an old colleague on the stairs, she was working in research and had a job going. My first reaction was negative, as research was like a swear word and I hated anything to do with research in my training but I went away, did some reading and decided to apply. I was shocked when I actually got it. I had no idea what I was walking into.

I absolutely loved it. It was so fast-paced, the workload was immense but the patient benefit was amazing. I could see positive outcomes, but it wasn’t only that. I was working with the same patients for a year or longer and built up rapport with them, and they spoke to you about everything that was going on with them. I loved it.

For me research has the best mix of autonomy and teamwork. You manage your own caseload but good communication across the team is essential. I also love the element of surprise … on one occasion I came in to find an email saying we needed to pull all of the patients on one of our trials off the drug immediately. I love that fast-paced excitement, it makes you grateful for the rare moments you do get to sit down at your desk and answer a data query.

My main passion is thinking about how we can unite clinical and research nursing.

I moved into the Comprehensive Local Research Network (CLRN) in 2009. To me it felt like a completely new way of thinking. You were working across such a wide area and with acute and primary care organisations that weren’t at all geared up for research. We had to be flexible so we could be responsive to the different needs of the Trusts. We also had to be sensitive to the internal politics, we were perceived as outsiders. It took a lot of thought and time to ensure we didn’t mess that up. But it was definitely rewarding.

In my role I have responsibilities for the Clinical Research Facility, research nurses within the trust and the CLRN. After that first conversation on the stairs I would have laughed if you had said I would be in this position now. I think research is still a dirty word amongst nurses. The most common reaction is ‘why would you want to do that’. It’s mainly a misunderstanding of the role, research used to be an easy role that people took when they are coming up to retirement. Once that perception exists it is hard to change. My main passion is thinking about how we can unite clinical and research nursing.

One of my main struggles is getting buy in from matrons on the ward. A lot hate research because they feel keeping posts open while nurse go on research secondments depletes their staff. For ward matrons they have targets and certain expectations to make their ward high quality and forward thinking. They don’t realise that we are feeding into that. I think some of the tensions arise because clinical nurses don’t realise that patient welfare and good patient outcomes are as central to our work. We need to stop speaking our own research language, go back to our roots and speak the same language.

After the Francis Report, nurses developed the 6 Cs to guide nursing – Care, Communication, Compassion, Courage, Competency and Commitment. If you think about what a research nurse does these are as essential to us as they are to clinical nurses. We should use this as a common language to unite us.

Supporting Surgical Trials

Joyce Katebe Clinical Trials Nurse, Surgery/Gastroenterology

I am a Surgical Clinical Trials Nurse and I trained and qualified in Zambia. My research started during post basic nursing training, during my BSc Nursing. Research was not part of the pre-registration nursing diploma/certificate then, but it was a requirement for the completion of the BSc Nursing.

After this, I became interested in research and was encouraged as I worked with my lecturers. I helped with data collection which I found very interesting and thought it was something I would like to do more of in the future. I was fortunate to be involved in research for the World Health Organization (WHO) on family planning in Zambia, and this inspired me to want to do more and helped me to develop my own questions about improving nursing practices to improve patient care.

While working in a local teaching hospital, I helped come up with a proposal about teenage pregnancy and the provision of ante-natal clinics for them. It was noted that most of them were first seen in labour when they were admitted to give birth. This prompted me to ask about what services were available for these mothers. I thought I would use this project to help set up ante-natal clinics for teenagers.

In research I find that there are many opportunities to learn.

Having moved to the UK and having spent time working in the NHS, I applied for a position at the Oxford University Hospitals. It was my first research nurse role and I worked with an enthusiastic professor who was very keen to involve nurses in his research. Very exciting. There were always new studies and each of the studies had different research questions to answer.

In my role, I was required to attend research meetings as well as having regular meetings with the principal investigators. I really got a buzz from these meetings as I felt really involved in trying to improve health of patients for the future. I lived in Oxford during the week and went home to Bristol at the weekends. Family life was difficult because my family stayed behind in Bristol and could not relocate as the children felt settled in their schools in Bath and were not keen to move to Oxford.

Many people when they hear the word research think having a career in research is beyond them, but in research I find that there are many opportunities to learn different things. I applied for my current position in Bath to help set up a research unit in the department of General Surgery and Gastroenterology. I was the first research nurse recruited to work purely for the two units.

Initially, it was a challenge because I had to find my way around the system. With the help of the surgeons and colleagues from oncology clinical trials unit, I had to look for office space, desk and all the equipment needed. I had to ensure that everyone joining the unit had Good Clinical Practice training and I went around the wards meeting the different specialists and nurses to discuss the research we did in the unit and this was repeated as required.

It is important that I develop good working relations with non-research nurses because most of my patients are in their care. It also allows them opportunity to understand the research we are doing. I meet patients in pre-op assessment unit, wards and in outpatients. The majority of them are keen to participate in research, the phrase I hear a lot from patients is "I am doing this because I want to give something back to the NHS and community at large” and some say "If no one did this years back, we would not have the treatment we have today."

To hear these words from patients is very encouraging. Many people when they hear the word research think having a career in research is beyond them, but in research I find that there are many opportunities to learn different things as well as witnessing how research is improving lives.

Developing Nurses

Lisa Berry, Senior Research Nurse, NIHR Wellcome Trust Clinical Research Facility, Southampton

The desire to be a research nurse came from a passionate belief that healthcare needs to be evidence based. It combines all the things that I enjoy; law, ethics, clinical care and working in complete partnership with research participants. At times, healthcare can be paternalistic. Patients come to us unwell and we do things to make them better.

Whereas in research the balance of power shifts considerably, we cannot achieve medical advances without help from patients (research participants). We work with them to assess the efficacy and safety of novel therapies and there is no guarantee that participating in a research study will be of benefit to the participant. In research, the safety and wellbeing of our participants is at the centre of everything we do and the research nurse is crucial to supporting them through the whole process of taking part in research.

Research nurses bring a study to life.

There are a specific set of skills that a research nurse needs. All the skills you learn on the ward are transferable and it is essential to have a good clinical grounding. You also need to pay attention to detail, understand the principles and importance of informed consent and be extremely organised. You need to understand not only the science behind the protocol but what participation will entail for the patients/healthy volunteers taking part.

Our nurses need to have the confidence to act as an advocate for the participant and must remain clinically relevant. We specialise in experimental medicine and provide care to healthy volunteers and patients with a wide range of disease and conditions. It is possible that a participant could become very unwell during a trial and therefore it is essential that research nurses remain sufficiently engaged with their clinical training to act appropriately and quickly.

Part of my role is to ensure that researchers are allocated appropriate levels of support and that the studies are set-up in a timely, safe and efficient manner and that we deliver an excellent standard of clinical and research care. Research nurses bring a study to life; they make a huge contribution to advancing healthcare and are a valuable asset for any research team. I was a Health Care Assistant before qualifying as a nurse. Although I am passionate about research nursing, this is not enough to build a career. I would not have progressed as quickly to the role of Senior Research Sister without support, mentoring and developmental opportunities.

Since I started in research in 2006 I have seen more career opportunities. More training has become available and there is a greater understanding of what clinical research nursing is. Even I didn’t really know what research nursing was when I started. We try to encourage our nurses to consider all their development options. We facilitate academic development as needed and also strive to provide career opportunities. A few of our band 6 and 7 nurses have been very fortunate in obtaining MRes funding. The NIHR funds the course fees, salary and also backfill for their position. The NIHR fund one person to do a Masters degree in research, but really they are funding the development of two people because someone else can then act-up into a more senior role and is also developed.

Our aim is to ensure that research is fully embedded within healthcare at this hospital. All research nurses now wear a dark grey uniform. This has given us a very visible identity and it is exciting to see how integrated into and dispersed around the hospital we are. Suddenly people become very much aware of the research presence in every division.

Informed Consent

Arshiya Pereira, Research Nurse, Renal Transplant Department, Central Manchester University Hospitals NHS Foundation Trust

I was trained in India to become a nurse. My first placement was in renal dialysis. I was interested in learning more about renal because of its vast subject area; renal medicine, renal transplant, research, transplant clinic and dialysis.

The main aim was to get more knowledge and experience working in a specialised unit. After moving to the UK I worked on the renal ward and dialysis unit at Sunderland Royal Hospital. I moved to Manchester as I wanted to gain more knowledge and experience of transplant. Initially working in the renal transplant clinic conducting follow up I became aware of research and I was curious about the research studies my patients had been recruited to. When a vacancy in Renal Transplant Research was advertised I applied.

I was a bit apprehensive in taking the role initially as I had heard many people say you lose your clinical skills and you do not get to take care of the patients as you would on the ward. I realise that those assumptions are inaccurate. I get to spend more time with the patients and I have discussions about the research. What we do in research today may change the way we practice medicine in the future.

Every day is different in renal research.

We work with two different types of donors, live donor transplant and cadaveric donors. With live donor transplant we know when they are coming to us. With cadaveric donors we don’t know when we are going to get the kidney. So I have to organise myself on the day itself. Recruitment always takes priority. The first thing I do each day is check if there are any transplant operations and if there are, I see if the patients are eligible for my study, and recruit them if they are happy to take part.

At times I have found it difficult to get the Principal Investigator (PI) to consent the patients because they were either in surgery or clinic. I began to wonder whether it would be possible for me to conduct informed consent? At the same time, the Trust was undertaking a scoping exercise to assess the need for clinical staff who were not doctors to take informed consent and developed policies and procedures to support us to take on this role. This is a wonderful opportunity for clinical staff who were not doctors to extend their role. Initially the role was delegated by the Principal Investigator who had to justify the need for a clinical research nurse to take the informed consent for a specific study. 

The main aim was to get more knowledge and experience working in a specialised unit. A half day training programme was developed to gain more in depth knowledge of informed consent and group activities to explore the issues and processes involved. My competency in obtaining informed consent was assessed by the PI. I passed and felt really proud of myself.

To take consent I screen the patients’ eligibility and send information sheets two weeks prior to clinic visit, so they have time to read the information and speak to family. I also consult with the respective surgeon to see whether they are happy for their patient to be approached for the particular study. When the patient comes to clinic I discuss the study and if they are happy to take part, I make sure they are fully aware of what the study involves. In total, I have taken 20 informed consents so far, which has enabled the team to recruit to time and target.

I have now been working in research for over five years. I feel that due to the skills and expertise gained in particular informed consent my leadership qualities have improved significantly. I ensure the patient feels valued, they are followed closely from their pre-transplant appointment to their aftercare and they always remember me for the care I provide for them.

Ruth Hulbert, Lead Nurse, Kent and Medway Comprehensive Local Research Network

I came into the NIHR from the pharmaceutical industry, working with GSK and then Pfizer, I was used to an environment where money was no object and it wasn’t necessary to get people on board with the idea of research. The need to influence the right people in order to get research done was completely new to me.

Clinical research nursing is definitely not for the fainthearted. Most people get into nursing for the patient contact. You still have that but you also get other experiences like handling data, project managing and making direct approaches to very senior managers and consultants. You have to be proactive which can be difficult. The patients don’t come to you, you have to go out and find them.

When I began in the Cancer Research Network my personal worry was about approaching patients to join a study. It is an unusual position for a nurse, you are asking them to help you. The first patient I recruited was a lung cancer patient for an observational trial. He was very receptive which gave me the confidence going forward.

Clinical research nursing is definitely not for the fainthearted.

Clinical Research Nursing comes with a lot of autonomy, you don’t get that freedom in other areas of nursing. Nurses are in a much better position now in clinical research as there is a much clearer career structure. Most nurses come into our CLRN as a Band 5 with some nursing experience. Our goal is to develop them, and within a year to 18 months, most become Band 6s.

Training is passion of mine. I think there is a lot of satisfaction to be gained in passing on your knowledge and skills to people who are new and inexperienced. It is great when you see people growing and becoming a more confident and competent version of themselves. I am one of the Network’s Good Clinical Practice facilitators. At the last facilitators meeting it was announced that we had now trained 30,000 people across the network, to be even a small part of that it great.

Clinical research nursing is definitely not for the fainthearted. I was twice involved in developing new networks in Kent and Medway; the Cancer Research Network and then the CLRN. There was very little research activity at the time but awareness of research is definitely starting to change. A major culture shift but there are still areas within our CLRN where there is no research activity. In the early days there was a mixture of lack of knowledge and lack of interest in research, but most of all the clinical staff didn’t realise we were there as a resource for them to handle the more time consuming aspects of starting up a trial. That has changed.

My hope is that within my lifetime research will be embedded into the NHS in Kent to such an extent that the public can go to their doctor and ask what clinical trials are available for them and their doctor will know. Wherever my career takes me from here, I know that I want to stay within research I have developed a passion for it.

Research Management

Debbie Beirne, Nurse Consultant, Cancer Research UK, Leeds

I loved research from the start. I loved the autonomy, responsibility, the degree of change, the degree of learning. When new nurses start with me I tell them that they will probably feel like a fish out of water for six months. I explain it is a very dynamic and interesting environment, not suitable for anyone who likes things to stay the same.

Adapting to change is probably the most important thing. With research we don’t want things to stay still, we want them to move forward and nurses have to be able to move with that. A big misconception is that research nurses float around with a clipboard, drink tea and work very standard hours. None of that is true. I don’t think that there is the appreciation that we are actually delivering care, not just writing protocols for others.

Research nurses can now have a role that is much broader.

I have several parts to my role – my day-to-day operational role, a translational development role, a role within my trust as a research expert for other departments, and my Cancer Research UK role in engaging with the public at events. I work with some of our clinician scientists to deliver their protocols. I help them look at what they are currently doing in the labs and how that could translate into patient care. As a result, I have some co-investigator roles on a few grants.

I have seen huge changes in almost every aspect of research since 1999, except for the fundamental of how we care for the patient. Research Governance has changed, the way we structure and deliver clinical research has changed, the way we inform people has changed. Clinical trials are much more complex than they were ten years ago, and so the role of a research nurse is much more complex too. It's a very dynamic and interesting environment, not suitable for anyone who likes things to stay the same.

Obviously medical science wants to engage with the public and keep them aware of advances but when a newspaper runs a 'magic bullet' headline it impacts the work I do. I frequently get calls from patients who don’t realise that the headline doesn’t relate to their situation or refers to something in a lab which could take us 18 months to translate. I think we have a duty to give people hope but make sure it is a realistic hope.

Research allows you a degree of personal and professional development in a more flexible framework than traditional nursing. There are lots of different avenues; Network managers and lead nurses, Trust and R&D lead nurses and new roles are always coming up. As recently as five years ago if you wanted to move beyond a Band 7 you had to leave nursing, now I am a Band 8b and still a nurse.

We need to move away from the idea that as a research nurse you are just picking up the trial and delivering it. Research nurses can now have a role that is much broader. You can be involved in writing the protocol, be a patient voice with scientists, change the research culture within the wider trust.

Patient and Public Involvement

Maggie Peat, Lead Research Nurse, Harrogate and District Foundation Trust and Patient and Public Involvement Lead North and East Yorkshire and Lincolnshire Comprehensive Local Research Network

I was working as a nurse giving chemotherapy. It was just at the start of the cancer research networks. I didn’t really have much idea about what research networks might do, it just sounded like a really interesting job. When I started there was a lot of feeling your way, there wasn’t a lot of guidance around. There is a lot more now. We mentor people.

We recognised fairly early on that most student nurses didn’t really know anything about research. I wanted to show them that it wasn’t just about systematic reviews and all the really dull stuff but about actually recruiting patients into studies and the really exciting stuff of being at the sharp end of research. Student nurses absolutely loved it.

Often patients will take part in research because it's for the greater good.

Some of the Patient and Public Involvement work has been about raising awareness because patients and the public have all sorts of good ideas that we don’t think of, like putting information up on screens in patient waiting areas. Everybody is doing that now but none of us had thought of that because we didn’t wait in the waiting areas. Accessibility to information is really important. The people who need properly accessible information the most, are the people who are least likely to ask because they don’t want to look stupid or think that they are going to be judged.

It’s a simple thing that after taking consent to say to the person "right I want to be really sure that you understand what you are taking on. So can you say to me, what you might say to your wife when you get home?" It is simple but nurses are not taught how to do that. It is important that we have tools to measure understanding.

The power imbalance between a nurse and a patient is less than between a consultant and patient. It makes it easier for a patient to say no to taking part in a study. It is important, that people can say no to a trial. Patients understand the incremental process of research. One of the things they say is "all that I have benefited from has come from someone else doing a study." Often patients will take part in research because it is for the greater good or sometimes it is a positive thing to come out of something bad that has happened to them. 

I wanted to show them that it wasn’t just about systematic reviews and all the really dull stuff. I think people are sometimes terrified of signing up for Patient and Public Involvement, thinking that they may have to do more than they want to do. So all our stuff is about saying to people, you can be involved as much as you want to be, you can do the occasional information sheet, you can look at a questionnaire and comment on it or you can come and be part of a steering group. People and patients can be involved in research as much or as little as they like.

NIHR has made it easier for consultants to take a study on, partly because of the nursing infrastructure. Nurses and support staff can work with consultants and we are here to stay. If you are interested in research nursing just do it, it suits most people. We have not had anyone work here that doesn’t love doing research.

Informing the Public

Karen Doyle, Senior Nurse, Cancer Research UK

When I started, research nursing was on the fringe of nursing. At the time we were told "you look after the doctors that is your role". That old fashioned view of nursing was still there.

I started in clinical research nursing because I wanted to be using all of the knowledge that I had gathered in my career. There were nurse specialist posts but I wanted something more intriguing, more complex. I didn’t want to do nurse management because it would take me away from patients. I always wanted to be patient centred. Research nursing offered all of that. I loved the fact that research nurses were involved in the science.

There were a lot of cancer patients with horrible side effects from the treatments available at the time. I wanted to be part of something that was not just accepting what we had because there was room for improvement. I wanted to be with the team that was making things better for these patients. Initially we were given early phase work such as toxicity and safety of the drug or treatment. So lots of additional testing. I loved the intensity and you got to know patients really well. I loved that in-depth interaction.

We are getting out into the communities with the right messages.

Medical teams sometimes want to get their patients into trials for compassionate, for misguided reasons. Sometimes you will get medical teams saying "But we have no other treatment to give them." You have to be strong. A clinical trial is not a treatment option and I think people forget that. We have to make sure that it is the right thing for the patient. That is what we are there for. When deciding if a trial is the right thing for a patient it is not only the science that matters. Sometimes it is the simple questions that matter for patients. Can you take tablets? Will you be able to cope with travelling to the trial? Those questions are missed if you haven’t got a nurse. We are the practical voice that makes the trial work.

I have developed my research nursing role to include informing members of the public about research. I love talking in the community because that is where the information is needed. We are getting out into the communities with the right messages – myth busting about clinical trials. Public understanding is better than it was but it has a long way to go. I have discovered that in addition to being face to face with the patient making the difference, I can also become the person (as a trainer) who will influence the nurses who are face-to-face. I can benefit many more patients through training than I could with nursing alone. I get a lot of reward from influencing other nurses. It is not management to me, management was taking you away from patients.

Research nurse leaders should be proud. We have taken the role of nurses in research from setting out someone’s lunch to a dynamic career. We have got national research nurse networks, we have got training and we have got the support of the NIHR. The change really is dramatic. I don’t know of any other type of nursing where it has improved as much and got more respect over time. You are really working as a specialist team member. That is the way it should be.

Claire Merritt, Lead Research Nurse Manager, Dementias & Neurodegenerative Diseases Research Network, Oxford

I caught the research bug in my first research post about 10 years ago. A consultant colleague had a grant to do a pilot study and asked me if I would be interested in working as a research nurse on their research study. 

I was the only research nurse and was responsible for recruitment and study delivery and very quickly learnt about how challenging it was identifying patients and accessing patients for research. Rightly, there are people who want to protect patients, but it’s about persuading them that research is a good idea. Encouraging them to introduce the idea to a patient can be hard. People think there is a large cohort of people out there for trials. In reality, the numbers are much lower than you expect them to be.

What we have done for the last seven years within DeNDRoN is about trying to facilitate a culture change within the Trusts and make research part of everyday thinking. We’ve introduced what we call link workers into teams. Each of the community mental health teams has an honorary research worker linked to it. This has been successful as they develop an understanding of what that teams needs and wants and how they work.

Working with patients is what nurses do best.

As well as building up a team it’s about building up an infrastructure to support research to happen. During the time I have been working with DeNDRoN the portfolio of research studies within Trusts has grown, as has the complexity of studies we are able to support. The key message is that research becomes embedded in patient pathways so it becomes everyone’s business and not just ours.

Our job is about helping to facilitate research to happen. Partly, that’s just continuously giving that message that research is an important activity. We’ve had a degree of success, but I think we still have a way to go to persuade all clinicians that research is their business. Some clinicians have bought into this concept well, some still argue they do not have the time to do research and some say they find research is something scary. However, research is about empowering patients and their caregivers and the general population to help.

You get a very interesting range of people who are keen to take part in research. Some people want to be able to access something that may make a difference to their relatives or themselves. Others have altruistic motives and want to help, because it will help others rather than help themselves. On the other hand some people don’t really understand what we mean by research, or feel it’s too scary or risky or too much of a burden. So education is important. We must always remember we work with people in crisis and sometimes it is not the right time for them to consider research.

Working with patients is what nurses do best. So for most research nurses the contact with patients bit deals with itself. There is though a lot to learn and it’s all the other stuff around research you have to work hard at. As a lead nurse most of my job is about providing clinical leadership to staff, making sure that things happen and supporting workforce development. Key to what I do is making sure we have the right people with the right training in order for us to do research that can go on to make a difference to people in the future. Everything we do is about forward thinking, you always have to be thinking about the future.

Toward the end of a long career in mental health nursing I am really pleased to have found myself following a career in research. I am quite passionate about working in research. You have to believe in research to make this job a success.

Patient Care

Kathryn Kennedy, Trainee Advanced Clinical Research Nurse Practitioner, Manchester Clinical Research Facility

When I worked as a clinical nurse we did not have that much interaction with the research nurses who came onto the ward, even though most of the children were on trial drugs with a protocol I don’t think I really understood what that meant. Because I was nosy and interested I got to know more about the research side of things.

When I started in clinical research nursing the studies were lower intensity to what we have now, generally well children in an out-patient setting. At first it felt like a little bit of step back on the clinical side but that gave me the opportunity to really develop my research knowledge.

The team is now dealing in phase 1, phase 2 trials now in children who have no other treatment options, sometimes quite unwell, so we are in the heart of clinical nursing on a daily basis. The role of the research nurse is critical to keeping families motivated to stay on the trial … we spend a lot of time ensuring that their journey through the trial is a positive experience.

Our expertise is essential in ensuring that the study runs smoothly.

I think the perception of losing the clinical part of the nursing role perhaps puts some people off. Friends have expressed that they would not consider research because they see it as a very academic, very administrative based role. That could not be further from the truth. We don’t cut corners with informed consent. Parents need to understand at a level where they are able to put their emotions to one side and make a decision based on the knowledge we have given them.

Some of our children come from Europe and can be re located in this country for up to 6 months with their family. The research nurse is very much responsible for that relocation, as the liaison with hospital services or sponsors, ensuring bank accounts are in place, other children are getting educated. A lot of biotech companies are new companies. It might only be their third or fourth clinical trial.

Our expertise is essential in ensuring that the study runs smoothly. It is not reasonable to involve parents in that process if these things have not been thought through. We are invited earlier now to go to (sponsor and management) meetings because they are recognising our expertise. We are the ones who understand how to get things right from the very beginning.

I am a trainee advanced practitioner due to qualify in September. It is really exciting to be the first. This is a brand new role to research; able to recruit children to clinical trials, deal with physical examinations, prescribe and see patients without the support of a medic. As an advanced practitioner we can provide support for PIs hopefully this will ease some of that pressure so that trials that we wouldn’t perhaps have been able to do, because there wasn’t the medical support, get done.

I wasn’t sure that research nursing was somewhere I would stay forever. I wanted the research knowledge and experience but knew that my heart would be in clinical nursing. This new opportunity coming along has allowed me to be even more clinical in research nursing.

My new role has generated interest from other nurses that did not know this kind of role would be possible in research. You get to make a difference in a very different way. I still get to look after sick children which is what I always liked about nursing. But now there is a deeper level to this.

Supporting Primary Care

Julia Rooney, NIHR Primary Care Research Nurse, Kent, Surrey and Sussex Clinical Research Network

I used to manage the cardiac care unit at Brighton for many years. I also had a period in the Middle East working in a heart centre. When I came back I worked for the heart network in Sussex where I also worked within primary care which was great experience as it is very different from secondary care.

I am now a research nurse working in primary care, coordinating and running studies in practices where there isn’t capacity to carry out research. I started in this post six months ago and I have found it to be a very fulfilling job for many reasons. It is so rewarding what you get back from patients who want to be involved in research for the greater good

In nursing you cannot move forward without research and we are an evidenced based profession, for example we wouldn’t have made the advances we have in the treatment of heart attack patients without research. The autonomy you get within this role and the one-to-one patient contact you have means the whole process is extremely worthwhile. I cannot recommend the role highly enough. I was looking for a something that would get me more contact with patients and a new challenge … it allows me to utilise my clinical background and experience within research and means I can make a difference that way.

As a nurse you always are an advocate for patients. You make sure they are the priority in the research.

I was apprehensive recruiting my first patient despite years of experience in nursing. I am a bit of a perfectionist and wanted to get it right, taking the informed consent, making sure the patients understood what they were entering into. Once you start it becomes very natural. In my previous position I was moving further away from patients and then this opportunity came up. Everyone who asks about my job I say 'I love it! There isn’t anything I don’t like about it'. People are probably getting a bit bored of me talking about it now.

I underestimated the job in the beginning. I knew it was something I wanted to do but I underestimated how much I would love it and how much of a difference I could make to patients’ lives. This will change lives for future generations. You actually get time with a patient. In that hour or so you can hear other concerns they have and you can talk to them and advise them. You get the opportunity to discuss issues that may be of concern to the patient.

My working days vary so much, for example for one study I arrive in clinic, order a courier to collect the bloods, get the clinic room ready and all of the paperwork. Then you consent the patient and run the study. I might have to then go to another clinic in another practice to complete paperwork or run a shorter clinic. I genuinely don’t have two days the same. If you have the clinical background just do clinical research. Until you are doing the job you cannot be sure how fantastic it is. The studies I am involved in will change lives. You cannot put a price on that.

Susan Read, NIHR Primary Care Research Nurse, West Midlands Local Clinical Research Network

Five years ago the Midlands Research Practices Consortium (MidRec) secured funding to recruit some half-time research nurse posts based in local GP research active practices. I’ve always been interested in research and was working in a very busy GP surgery at the time, seeing patients every 5-10 minutes, with no quality time available to spend with my patients. I thought this job would give me the opportunity to spend more satisfactory time with patients while becoming involved in gathering accurate information to provide evidence based medicine.

I was the first nurse appointed and now part of a successful team of six nurses, based in our own individual surgeries, overseen by a Lead Research Nurse. Before we started running research studies in our nominated surgeries our Lead Nurse manager ensured that we underwent a programme of mandatory training so we had an understanding of what was required to safely be involved in research.

We have this supportive network of research nurses which makes for a powerful effective team.

Gradually the studies came in and I remember being asked by Professor McManus how many studies we were running and I said we were currently running about 20 studies. He was surprised. I think that opened the GPs’ eyes and they realised the opportunity they had with the support of the nurses.

Many studies are observational where you are looking and extracting data. We also look at feasibility of studies, so we are contacted by a study manager and asked to find out the number of patients we have. So we can go back to the study team and say these are the numbers for this head of population which we think you will be able to access at these surgeries.

The medical knowledge nurses have comes in useful when running feasibility studies. We can search effectively for eligible patients. We significantly help the GPs. I remember my first patient recruited to a study. I was absolutely thrilled because patients were willing to participate in the study where we were doing near patient testing and baseline health measurements with immediate feedback of results which we then had time to discuss. If necessary the patients could be referred back to their GP for any concerns that were highlighted.

The patient contact, the communication pathway that opened up in the last five years with the team has given me job satisfaction. We really feel included more so now than ever before. What pleases me the most is that although we are autonomous within our own environment there are five other host nurses. We have this supportive network of research nurses which makes a powerful effective team. We have opened up effective pathways between the university, study teams and other professionals. If they need help or an answer to a query we can normally provide the information quickly and efficiently because we have close contact with the GPs.

If someone is considering a career in research I would say come and join me for a day and see things first hand. Many of the host nurses have come from a Practice nurse background and have a wide range of knowledge because you can in any given day look after babies, give travel jabs, look after women’s health to caring for a patients with a chronic condition. Over the years our training has covered an enormous remit.

You learn a lot from problems, you have to be pragmatic and always look for solutions. When they set up this scheme, we were a pilot study. The success of the Pilot enabled funding to continue and currently the NIHR fund us through their networks even after MidRec itself came to an end. Patients deserve the opportunity to be involved in research.

Building Social Media Networks

Nathaniel Mills, Research Nurse Manager, Clinical Research Network: Yorkshire and Humber

My research career started in 2007. I was working in a large teaching hospital, part-time research and part-time primary care. When I started there was some negativity around working in research from colleagues who thought it was not real nursing. They thought it wasn’t direct patient care. But for me it was something I felt I could do to make a difference.

The whole notion of improving health and wellbeing through research appeals to me. I joined the NIHR Clinical Research Facility in Sheffield when it was a relatively new facility and I was in one of the first cohorts of research nurses. As a novice to clinical research you think ‘what’s it all about?’ but with experience and as time goes on, you physically see a patient’s symptoms improving. That gave me a great deal of job satisfaction.

In some cases the patient you see at the beginning of a trial is different to the same patient at the end of the trial. This is not just because they have had an trial intervention but because you, the nurse and the research team have given them the support and care that comes with trial participation.

I am passionate about twitter because it pulls together these groups of people who have common themes and needs.

When the NIHR Coordinating Centre began to consider social media as a tool to support research staff and utilise established tools, I became involved in the work of the NIHR Clinical Research Network Nurses Strategy Board. I met up with Fiona O’Neill, a few colleagues and Teresa Chinn from ‘@WeNurses’ to start up a clinical research nursing network on twitter. Teresa was inspiring in the sense that she’s a nurse working on her own and used social media to connect with other nurses. She now has a community of over 10,000 active and innovative followers.

So we developed a social media strategy (#crnnurse) with the aim of connecting the clinical research nursing community - especially reaching out to those nurses working in silos, something which is common in clinical research. We advertised this through the Clinical Research Network newsletter, and widely on Twitter we have regular ‘tweet chat’ debates and anyone who has anything to say about clinical research can participate - this has led to an active and vibrant community on social media.

Sometimes I get the odd negative responses such as 'I don’t want to do this in my own time' or 'what’s the point?' and that’s the beauty of it, you don’t have to, you can participate as much or as little as you like, the conversation is always going on.

Since its launch we have achieved a lot. We have a community of nurses and international nurses from the USA, Australia, South America and North Africa. We promote good practice and social media brings the learning to the community ... it’s free, cheap and easy. People who link in to our network can find out which Trusts are running trials. Problems can be shared rather than dealing with them by yourself, because it is highly likely someone will have already encountered the problem. So I would encourage nurses to get out there and start networking through social media, it can help make the life of clinical research nurses much easier.

I think the future is whatever you want it to be in terms of social media. If we do it right we can respond to what the nursing community wants. I am passionate about twitter because it pulls together these groups of people who have common themes and needs. Of course we have to consider what we say on a public forum, but we are all professional nurses and we are accountable for our actions. Follow me @natwm10 or @resnurse.

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Clinical Research Nursing

The specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. This specialty practice incorporates human subject protection; care coordination and continuity; contribution to clinical science; clinical practice; and study management throughout a variety of professional roles, practice settings, and clinical specialties.

Please cite International Association of Clinical Research Nurses. (2012) "Enhancing Clinical Research Quality and Safety Through Specialized Nursing Practice". Scope and Standards of Practice Committee Report.

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Professional identity and the Clinical Research Nurse: A qualitative study exploring issues having an impact on participant recruitment in research

Affiliations.

• 1 County Durham & Darlington NHS Foundation Trust, University Hospital of North Durham, County Durham, UK.
• 2 Rehabilitation Department, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
• 3 The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
• PMID: 28792610
• DOI: 10.1111/jan.13409

Aims: The aim of this study was to explore the experiences of Clinical Research Nurses, with an emphasis on factors that may have an impact on successful study delivery.

Background: The Clinical Research Nurse workforce is pivotal to improving health outcomes through supporting research-active health economies. Investment in research infrastructure has led to nurses and midwives increasingly undertaking extended roles to deliver clinical research. Despite such opportunities, the recruitment of sufficient participants into research studies remains problematic. A growing body of literature is exploring barriers to successful study delivery, indicating the emergence of a caring-recruiting dichotomy in clinical research staff.

Design: This qualitative study investigates the experiences of Clinical Research Nurses delivering research in the United Kingdom National Health Service.

Methods: Four Focus groups (total 19 participants) were conducted in a large North East National Health Service Foundation Trust from November 2015 - February 2016.

Findings: Thematic analysis identified perceptions of the role in the wider context of professional identity. Role transition, altered relationships and workload complexity, affected participants' practice, leading to inconsistency between core clinical values and perceived identities as research delivery staff. A duty of care as patient advocates contrasted elements of the work reflecting that of salespeople. The emotional labour of approaching patients and unease regarding peer perceptions of the Clinical Research Nurse role, affected the positive aspects of research delivery.

Conclusion: Professional-identity and self-concept appear to have an impact on practice in a research delivery role. Further research should explore these issues further, to enlighten the basis on which such feelings are positioned and to work towards practical solutions.

Keywords: UK; clinical research; clinical research nurse; informed consent; nursing; participant recruitment; professional identity; qualitative research; self-concept.

© 2017 John Wiley & Sons Ltd.

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Back to School for Graduate Studies in Clinical Research: A Snapshot of U.S. Programs

Blog September 12, 2024

As students and faculty began settling into the routines of a new academic year at universities across the U.S., ACRP reached out to experts from graduate programs in clinical research for a snapshot of how education in this field, especially at the master’s degree level, is holding up amidst rapidly evolving changes in the research enterprise itself. Presented below is the feedback we received from academicians at the University of Arizona, Rutgers, and University of Southern California who were generous with their responses at this busy time of year for their programs.  

Helping to keep us up to date on trends among clinical research graduate students are:  

ACRP: How well prepared are incoming students in clinical research master’s degree programs for their studies in the face of ongoing, rapid advances in the profession?  

Celaya: Many students are coming to our clinical research programs with diverse backgrounds and preparedness. Some are recent undergraduates and others mid-career professionals or clinicians. Even though these students come to us with strong scientific backgrounds, many of them need a deeper understanding of regulatory fundamentals, data management skills, and the knowledge of ethical considerations when designing clinical research projects. We are starting to integrate clinical research coursework in each level of student and trainee engagement to better position students for success in their graduate studies.  

Lechner: The incoming students to our master-level clinical research degree are from many different backgrounds and come from varying levels of preparedness. However, our master program has rigorous entry requirements including written and oral communications, which allow the best students to be brought into our program, ready to hit the ground running with their studies. Most of the students adapt rapidly after completing the foundational courses.  

Succar: The exciting world of clinical trials and research has seen tremendous advances in the profession, and while our incoming students often have strong medical, health, science, and clinical backgrounds, many are underprepared in terms of specific competencies, skills, and knowledge needed to conduct and manage modern clinical trials and research teams.  

Many incoming students in our programs come from varied professional backgrounds, including physicians, pharmaceutical industry employees, and PhD and postdoctoral students. This diversity suggests varying levels of prior research experience and knowledge. To address gaps in preparation, we have developed more accessible curricula integrating Good Clinical Practice, research processes, and regulatory requirements.  

Furthermore, the rapid advances mean even experienced professionals may need additional training since clinical researchers need to be competent in areas such as following complex regulatory requirements; ensuring compliance, ethical study conduct, and participant safety; communicating effectively with research participants; leading diverse research teams; and understanding study design, statistics, and data management. [These competencies are covered in more detail in a forthcoming article coauthored by Succar for ACRP’s Clinical Researcher journal.]  

The responsibilities and skills required of clinical research professionals have expanded over time. Many students interested in becoming clinical researchers struggle to find formalized training that prepares them to conduct safe, well-designed clinical research. Thus, our programs continue to evolve and adapt to provide more accessible options to help students gain these competencies. Ongoing evaluation and curriculum development are conducted to ensure our programs adequately prepare incoming students for the evolving demands of clinical research careers.  

ACRP: Are the kinds of undergraduate programs the younger students are coming from giving them a good leg up on tackling graduate studies in the field?  

Celaya: Traditional students coming from undergraduate training in health sciences or clinical disciplines often have a solid foundation. But since clinical research is a field that is constantly changing, these students still need a foundation that their traditional science backgrounds don’t necessarily give them in a scholastic setting.  

Succar: Unfortunately, there is limited education and training specific to clinical trials and research in undergraduate programs. We have a diverse cohort of incoming students with a range of experiences from years of extensive clinical research experience to no experience at all. Thus, we offer programs designed to help undergraduates prepare for graduate school, providing research experience and mentorship to undergraduates. For students coming from non-science backgrounds, we also offer science enrichment courses to help them prepare for our programs.  

On the flip side, students coming directly from undergraduate programs may have some advantages, as they are likely more accustomed to the academic environment and study habits required for graduate work. Recent exposure to foundational coursework may be fresher in their minds. They may have more flexibility and fewer outside commitments compared to older students who are balancing work and family responsibilities.  

Ultimately, success in graduate studies depends on individual preparation, motivation, and the specific skills and experiences gained during undergraduate education, regardless of age. Both younger and older students can excel in graduate programs if they have adequately prepared themselves and chosen a program that aligns with their goals and background.  

ACRP: Are the older students coming in for advanced studies as ways to change careers or climb their existing clinical research career ladder able to prepare themselves well for graduate studies based on resources from the graduate programs or elsewhere?  

Celaya: Non-traditional students, many of whom come from established careers in healthcare or related fields, bring practical experience to the table, often in areas like nursing, clinical areas, data management, or regulatory affairs. Many of them come to us from entry-level clinical research jobs. Their real-world experience is invaluable, but transitioning into academic study can present a different set of challenges, particularly for those who have been out of formal education for several years. In these cases, we’ve found that graduate programs need to offer additional support, such as modules or refreshers on academic writing, research methodologies, and current industry standards. Many programs, including ours, have started providing resources like boot camps or online primers to help these students bridge any knowledge gaps and ease back into academic life.  

Lechner: The master programs built for today’s working students are rigorous and allow application of what they have learned in their career and the classroom. Their professional experience allows them to build on their solid foundation, and our program fine tunes the gaps as they continue in their course journey.  

Succar: Adult learners often have different needs compared to traditional students coming directly from undergraduate studies, and the Master of Science in Clinical Trial Management is perfect for those learners seeking a career change or promotions within their existing clinical research careers and institutes.  

In addition, our institution offers career planning and development resources and courses specifically designed for older graduate and postdoctoral trainees in clinical research. These courses increase career readiness and awareness of career options for graduate and older students, which helps to expand their awareness of careers that align with their advanced skill sets.  

Many older students are employees with families who study as part-time rather than full-time students, so taking advantage of these career planning courses and resources offered is beneficial for them. We also offer mentoring opportunities, as mentoring relationships can be valuable for career development, as well as flexible scheduling and delivery options to accommodate work/life balance.  

Adult learners can leverage their work experience and transferable skills from previous careers and develop new career adaptability skills to navigate transitions. We accommodate the needs of adult learners and offer opportunities for both career changers and those advancing in their existing clinical research careers.  

ACRP: Can these academic programs really keep up with ever-changing developments in the field these days?  

Celaya: The landscape of clinical research education has rapidly evolved. Many changes have come about due to the need to keep pace with advances in technology, regulations, and research methodology. This can definitely be an issue for master’s programs that are stagnant within the same curriculum year to year when so many changes are happening in the regulatory arena, artificial intelligence, industry connection, and dissemination of scholarly activity. We take a more agile approach by examining the curriculum on an annual basis to make sure we adapt to those changes. We also have content experts as guest lecturers who are currently working and developing clinical research projects in real time. This allows our students to hear from faculty who know about current trends and include any anticipated changes. We also partner with our university clinical research office to ensure we are giving the most current information. A close relationship between academia and industry is essential for ensuring that graduates are well-equipped to thrive in this dynamic field.  

Lechner: Academic programs such as ours have advisory boards, core faculty, and adjunct faculty who are deeply rooted in clinical research management and who collaborate to assure our program is current with today’s environment. Our program allows faculty time to update their course content on an evolving basis to keep current with the ever-changing developments in clinical research as well as to include recent case studies. In addition to the more basic courses which lay out the foundation of the regulations and guidance, the program includes coursework to allow “hot topics” in the clinical research enterprise to be presented to the students.  

Succar: The dynamic nature of clinical trials and research means that formal education and continuous learning are necessary for professionals to remain up to date with the ever-changing developments in the field. Our department embraces these innovative changes and has established strong collaborations and relationships with pharmaceutical, biotech, and academic institutions to provide students with opportunities to pursue current clinical research projects and remain abreast of ongoing developments.  

Some of our adaptations include bringing in industry experts as guest lecturers or adjunct faculty; offering internships and co-op programs for real-world experience; and developing joint research initiatives on cutting-edge topics. These partnerships help our programs to stay more closely aligned with industry needs.  

We frequently update our curricula to incorporate emerging technologies and industry trends, by adding new courses on topics like artificial intelligence, machine learning, and data science; integrating project-based learning to give students hands-on experience with current tools and practices; and offering specialized tracks or concentrations in high-demand areas.  

I believe that a combination of formal education and continuous self-directed learning is necessary to truly keep pace with industry developments.  

Edited by Gary Cramer  

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Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. Collaborates with research team to assess feasibility and management of research protocols. Ensures implementation of research protocols after IRB approval and provides information as appropriate for progress reports. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Manages, monitors, and reports research data to maintain quality and compliance. Provides education/training for others within the department. Performs administrative and regulatory duties related to the study as appropriate. Some travel may be required. ADDENDUM (if applicable) Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. Participates in other protocol development activities and executes other assignments as warranted and assigned. 

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Work alongside a diverse and supportive environment to push cancer research forward. You will work directly with a broad range of MDs/DOs, a variety of patient populations, and a dynamic team. Hematology is at the forefront of cancer immunology research; you will play a significant role in progressing cancer research to the next chapter. You will have the opportunity to use your research skills to serve as a leader and SME in patient care. 

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Management information on recruitment to clinical research studies

Published 12 September 2024

© Crown copyright 2024

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected] .

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/management-information-on-recruitment-to-clinical-research-studies/management-information-on-recruitment-to-clinical-research-studies

Data on the recruitment to clinical research studies, reported to the Department of Health and Social Care ( DHSC ). This release is published as management information, in accordance with the Code of Practice for Statistics , to improve transparency and support publication of the Darzi review on 12 September 2024. The Darzi review is the independent investigation of the National Health Service in England, led by Lord Darzi.

Clinical research studies are important for advancing medical knowledge and enhancing patient care. These investigations are designed to evaluate the safety, efficacy and effectiveness of new treatments, medications, devices, or interventions. Clinical research includes various types of studies, such as clinical trials and observational studies.

Clinical trials, also known as interventional studies, test new medical approaches, including drugs, vaccines and surgical procedures. They are carried out in phases to assess safety, dosing and effectiveness. Observational studies monitor and analyse the effects of specific variables on health outcomes without intervening.

By systematically investigating in this way, clinical research plays a vital role in discovering new treatments and improving healthcare practices.

Monitoring clinical research delivery

One of the ways clinical research delivery in the UK is monitored is through the UK Clinical Research Delivery Key Performance Indicators Report . This report, previously known as the Research Status Report, brings together data from the National Institute for Health and Care Research ( NIHR ) and the Medicines and Healthcare products Regulatory Agency. It monitors progress on delivering parts of the government’s vision for UK clinical research delivery. The performance indicators measure trends in:

• the speed and predictability of regulatory and study set-up timelines
• the delivery of research to time and target
• overall recruitment levels

The report is published monthly by DHSC and is being used to support the development of policies to encourage clinical research delivery.

This publication focuses specifically on clinical research recruitment data from the UK Clinical Research Delivery Key Performance Indicators Report from April 2014 onwards. It is a supplementary management information release, showing detailed tables behind the recruitment charts published in June 2024’s UK Clinical Research Delivery Key Performance Indicators Report.

Definition of a research study

Research is defined in the UK Policy Framework for Health and Social Care Research as the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods. This excludes: audit, needs assessments, quality improvement and other local service evaluations. It also excludes routine banking of biological samples or data except where this activity is integral to a self-contained research project designed to test a clear hypothesis.

This definition applies to all studies for which NIHR Clinical Research Network support is sought regardless of the study type or research funder.

Table 1 shows the number of participants recruited into studies since April 2014, held on the NIHR Clinical Research Network’s central portfolio management system.

The central portfolio management system consists of all studies held on the Clinical Research Network portfolio, as well as some studies held on the network portfolios of Northern Ireland, Scotland and Wales.

The data includes recruitment to both interventional and observational studies. The data represents the total number of participants recruited for a given month, based on the month and year the recruitment notification was received.

Table 1: recruitment to clinical research studies

Source: NIHR Clinical Research Network, central portfolio management system

Table 2 shows the number of participants recruited into studies since April 2014, held on the NIHR Clinical Research Network’s central portfolio management system.

Table 2 includes recruitment to 3 study types:

• commercial contract studies. These are studies sponsored and fully funded by the life sciences industry
• commercial collaborative studies. These are studies typically funded, wholly or in part, by the life sciences industry and sponsored by a combination of life sciences industry and non-commercial organisations. This category has previously been included in non-commercial figures but it is now being presented separately to better represent the breadth of commercial studies. Commercial collaborative studies are supported in the same way as other non-commercial studies
• non-commercial studies. These are studies sponsored and wholly funded by one or more non-commercial organisations, including medical research charities, universities and public funders such as NIHR and UK Research and Innovation

The data includes recruitment to both interventional and observational studies.

Table 2: recruitment to clinical research studies broken down by study type, 2014 to 2024

Methodology and quality note

Inclusion and exclusion criteria.

Recruitment is only recorded in the central portfolio management system if it meets the definitions of recruitment as outlined in the NIHR Clinical Research Network Recruitment Policy Document . For example, recruitment data is not collected for studies classified as non-consenting. These are exceptional circumstances where no form of consent can be obtained.

Only research activity with a status of confirmed and provisional is included. Research activity which is indicated as inaccurate (queried) is excluded from figures.

Confirmed status includes manually uploaded data or data from the local portfolio management system that has been confirmed as accurate by the Chief Investigator, their representative or a representative of the commercial sponsor or contract research organisation.

Provisional status is given to data from the local portfolio management system that has yet to be confirmed or that requires reconfirmation following queries.

Data source and coverage

The data has been sourced from the central portfolio management system. The central portfolio management system consists of all studies held on the Clinical Research Network portfolio, as well as some studies held on the network portfolios of Northern Ireland, Scotland and Wales.

The data is recorded monthly from April 2014 to March 2024. For the purpose of the UK Clinical Research Delivery Key Performance Indicators Report, monthly snapshots are taken according to a data cut schedule. The snapshot used in this publication was taken on 21 June 2024.

Data caveats

The data does not show recruitment to the whole clinical research system, only recruitment to studies on the central portfolio management system. Therefore, this data will be an underestimate of total clinical research recruitment in the UK.

The data is not exclusive to NHS sites and includes recruitment to non- NHS sites.

While data covers the whole of the UK, data relating to studies led by devolved administrations may be incomplete. This is because they are only included in the central portfolio management system when added by the devolved administrations.

The quality of the data is dependent on the accuracy and timeliness of recruitment data being recorded in the system.

There is often a lag between activity taking place at a study site and data being recorded in the system. This means that previous months’ data may be updated retrospectively. Changes in recruitment for individual recent months should not be taken as an indication of overall trend in recruitment.

From the 2023 to 2024 financial year onwards, the data for the commercial collaborative category will be more robust. This is due to data quality improvements linked to reporting this category separately, instead of classifying activities as purely commercial or non-commercial. Not all studies will have been reviewed retrospectively and re-classified where necessary, particularly studies that had already closed.

Using the data

The data cannot be used for:

• measuring overall UK study recruitment as the data is only on studies on the central portfolio management system (not activity of the whole research environment). It is unknown what proportion of studies in the UK at that particular point in time are contributing to the figures
• comparing (portfolio) recruitment over the time. The network as an organisation and its remit has changed significantly over time. Caution should be taken with time comparisons as portfolio and associated data collection may have changed
• UK-wide data within the central portfolio management system across years. It has only been in recent years that UK-wide data for commercial (for example) has been collected into the central portfolio management system

The portfolio balance between observational studies and interventional ones will influence the numbers. For example, if at a particular time, the portfolio has some large sample size observational studies, this will affect recruitment numbers and make it difficult to compare to other years.

Recruitment from private sites may not be collected and so may not be included in the data.

If you have any questions in relation to these statistics, please contact [email protected] .

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• Open access
• Published: 12 September 2024

Improving the quality of clinical training in maternal and neonatal health in undergraduate nursing students: a participatory action research

• Akramsadat Sadat Hoseini 1 ,
• Fatemeh Ghasemi 2 ,
• Fatemeh Valizadeh 1 ,
• Nahid Dehghan Nayeri 3 ,
• Tahereh Toulabi 4 &
• Shirin Hasanvand 4  

BMC Nursing volume  23 , Article number:  647 ( 2024 ) Cite this article

Metrics details

Improving the quality of clinical training is synonymous with accomplishing nursing education goals and improving the quality of nursing care. This study aimed to improve the quality of clinical training in Maternal and Neonatal Health (MNH) in nursing students.

This action research was conducted in two cycles from June 2017 to June 2018. The study setting was the School of Nursing and Midwifery of Lorestan University of Medical Sciences in southwest Iran. The participants were nursing students, faculty members, clinical trainers, educational managers, and teaching personnel. In the first cycle, semi-structured interviews were held with stakeholders to identify clinical problems and improvement strategies. Based on the results of these sessions, the changes needed to improve the quality of clinical training were planned and implemented. The weaknesses and strengths of the implemented changes were then identified through group discussions with the stakeholders. In the second cycle, a second plan was carried out to correct the weaknesses of the changes planned in the first cycle, and the modifications were implemented and evaluated.

The main three categories extracted included an unsystematic curriculum and inadequate monitoring, inadequate resources and facilities, and the student’s lack of motivation. The measures taken for improvement included holding communication workshops, developing and internalizing logbooks, reducing the number of students in clinical training groups, using modern clinical training methods, and changing clinical evaluation methods.

Improving communication skills among the students, trainers, and hospital personnel and using modern clinical training methods, such as conceptual maps, triple jumps, and clinical skill centers, are the best strategies for improving clinical training in MNH nursing students.

Peer Review reports

Maternal and neonatal deaths are key indices showing countries’ health and hygiene status. Improving the level of care is the best way to reduce maternal and neonatal mortalities [ 1 ]. As healthcare providers, nurses are the backbone of health systems [ 2 ]. Nursing schools aim to train nurses capable of providing clinical services following modern scientific advances and meeting the community’s needs [ 3 ].

Clinical training has a significant role in achieving this goal as the heart of nursing education [ 4 , 5 , 6 ]. Management is essential since students’ clinical training is complex [ 7 , 8 ]. In a study based on the opinion of nursing graduates, 80% of the skills acquired during their studies were average for the work environment [ 9 ]. Also, evidence suggests that clinical nursing faces many challenges and problems in various domains, including MNH [ 10 , 11 , 12 , 13 ].

Based on the literature, the teaching quality of the mother and newborn course is in the last ranks of the undergraduate nursing courses, and the average sufficiency of the internship of this course for the acquisition of clinical skills of the students from the perspectives of the teachers in the rank after the fundamentals of nursing, management, community health, psychiatric nursing, pediatric and medical - surgical nursing. In comparison, this lesson has particular importance for the health of society [ 12 , 14 ]. This is while the neonatal period is crucial for quality care due to the need for multiple adaptations to compromise with extrauterine life and the vulnerability of the newborn [ 15 ]. Lack of standard care is associated with long-term complications during infancy, some of which affect the person until the end of life [ 16 ]. Also, physiological changes during pregnancy and after in women entering the role of the mother increase their need for care [ 17 , 18 ]. The best place for training and improving nurses’ knowledge in caring for mothers and newborn are the theoretical and clinical course of MNH for nursing students. Because at birth and a few hours after birth, the first ones who are in contact with the newborn and the mother and have a significant role in the care and education of these vulnerable groups are nurses; they should prepare this before entering the field of work and get an entire and decent career.

As future nurses, today’s nursing students need to gain the required readiness and competence to provide maternal and neonatal care through improved quality clinical training in MNH. The present study was conducted to improve the quality of clinical training in MNH among nursing students using the action research approach, which combines practice and research and replicates what happens in the real world. This approach is systematic research and an intellectual reflection on the change process [ 19 ] and has a significant role in improving the quality of nursing education [ 20 ].

Design and setting

This action research was conducted from June 2017 to June 2018 in two cycles, each consisting of four stages: identification, planning, implementation, and evaluation.

The study setting was the School of Nursing and Midwifery of Lorestan University of Medical Sciences in southwest Iran. In this setting, nursing students receive four years of training and start working in hospitals after obtaining their bachelor’s degree. MNH is taught to them as a theoretical and clinical subject. The clinical part of the training was held for 5th and 8th -semester students in maternity, maternal and neonatal wards (51 h each) with the full-time presence of a faculty member or a non-faculty instructor in groups of nine to ten students. Due to cultural, belief-related, and legal issues and to respect the patient’s right to receive the services of a same-sex nurse, clinical training on this subject was solely provided to female nursing students, and no male nursing students received any clinical training in the maternity, maternal and neonatal wards [ 21 ].

Intervention

The present participatory action research was conducted using quantitative and qualitative approaches in two four-stage cycles, with a reflection on each stage based on Speziale et al. (2011) model. The Speziale model, rooted in participatory action research (PAR) principles, emphasizes collaborative inquiry and reflection and was aligned well with our goal of enhancing clinical training quality through active engagement of stakeholders [ 17 ] (Diagram 1 ).

An overview of the steps of participatory action research to improve the quality of MNH courses

This cycle consisted of identifying the problems and strategies, planning, action for change, and evaluation.

Identification

Step 1 ( quantitative approach ).

This stage aimed to investigate the educational situation of the MNH clinical course. The data was collected with the Iranian questionnaire on the clinical education situation. The whole enumeration method selected students who completed the MNH clinical course (number = 16). The instrument was completed as a self-report. This instrument was divided into two parts: the demographic characteristics of the learners and the second part comprising: 33 items and five dimensions: objectives and curriculum (11 items), teacher performance (9 items), communication with students (4 items), educational environment and resources (5 items) and monitoring and assessment (4 items). Answer questions based on a three-point Likert (yes (3 points), slightly (2 points), and not (1 point)). The results ranged from 33 to 96 to 66 − 33, indicating the unfavorable level, and 99 − 66, the favorable level of clinical education. The mean scores for each domain were calculated by adding the scores for the items and dividing them by the item number. Ghafourifard reviewed and confirmed the validity of the instrument [ 22 ]. Computing Cronbach’s alpha confirmed its reliability at 0.99.

Step 2 ( qualitative approach ).

A qualitative content analysis study was conducted to identify the existing problems of improving the quality of clinical training in MNH. The participants were selected through purposive sampling. They included faculty members, clinical trainers, teaching hospital personnel, and students who had already earned or were earning clinical credits for this subject and had objectively experienced the problems of clinical training. Sampling continued until data saturation was reached. Data were collected through semi-structured, individual, face-to-face interviews and focus group discussions.

The interviews began with the question, “How do you evaluate your clinical training on MNH?” or “Describe your experiences of the clinical training of MNH.” The participants were asked to talk about their problems concerning this subject. The interviews lasted between 45 and 90 min. Focus group discussions were also held to obtain appropriate information, brainstorm, and complement each other’s statements about the problems of MNH training. The groups were homogeneously formed so the participants could freely express themselves in a comfortable setting. The faculty members and personnel formed one group, and the students formed a separate group. One of the research team members took part as the group assistant, and the first author was the facilitator. The group discussion questions were based on the problems stated in the individual interviews and aimed to assess strategies and activities for affecting change. The researcher reminded the participants that the goal of the sessions was not to reach a consensus but to gather data based on their experiences and opinions. Each group consisted of six to eight members. Overall, four 1.5 to 2-hour sessions were held.

All of the interviews were audio-recorded and transcribed verbatim. The data were analyzed in MAXQDA-10 using the approach by Graneheim and Lundman [ 23 ]. The problems and strategies were explained and confirmed by the end of stage one. The rigor of qualitative data was confirmed by Lincoln and Guba’s method. The familiarity and professional involvement of the first researcher in the research setting for more than 20 years and the researchers’ long-term engagement and allocation of time for data collection helped gain participants’ trust and thus enriched the data. The research team reviewed, analyzed, and categorized all the codes until the codes, subcategories, and main categories were identified to increase data credibility. The extracted data were then reported to the participants to examine whether they conformed to their experience, and the necessary corrections were applied. Numerous data collection strategies, such as focus groups and semi-structured interviews, helped enrich the data. The external observer method was used to confirm the dependability of the data.

The problems and strategies were explained and confirmed by the end of stage one.

The previous stage’s results were analyzed with two group discussion sessions, and a list of problems was prepared. Then, the challenges were prioritized based on urgency, importance, impact, and ability to solve the problem. Next, strategies and action plans were designed. In this stage, a reform group was formed in the school consisting of the faculty director, the school’s clinical affairs officer, the department head, and faculty members from the pediatrics, maternal and neonatal departments. The first session revolved around funding and supplying the human resources needed to implement the action research for change. The second session was held to decide how clinical training should be carried out based on the plans proposed by the participants.

Action for change

Actions planned based on participants’ views and with the change group were implemented (Table  1 ).

Cycle one was evaluated once a week and at the end of the fourth week of the academic semester through individual and group interviews with the stakeholders to reflect on the change implementation process, and clinical training was thereby assessed. The problems and strategies used were evaluated according to the views of the participating trainers and students through two group interviews with the 5th-semester nursing students (four girls) and four professors (three from the pediatrics and one from the midwifery departments), and the weaknesses and strengths of the changes were identified. The comments made by the ward officials and stakeholders were noted and recorded daily, and these groups were invited to participate in the final evaluation interviews if desired. Table  2 summarizes the results related to the planning, implementing, and evaluation strategies proposed for improving the quality of clinical training in MNH.

The second cycle was carried out in four stages to correct the changes implemented in cycle one. This cycle also included identification (the weaknesses and strengths of cycle one), planning, action to repair, and evaluation stages. The second cycle started from the eighth week with two change program working groups consisting of MNH group managers and representatives of students and professors who had experienced the change program to strengthen the strengths and improve the weaknesses of the strategies implemented in the first cycle. Two group interviews were done with students, instructors, and staff in this phase.

Following the evaluation of cycle one and determining the strengths and weaknesses of the implemented changes, two focus groups of stakeholders were formed to provide corrective recommendations. Changes were then planned and implemented based on these recommendations.

Ethical considerations

This AR was approved by the Research Ethics Committee of Lorestan and Tehran Universities of Medical Sciences. All the participants were informed of the study’s objectives and were free to express or withhold information. The duration of the interviews was set based on their physical and psychological states. They were reminded that they could end the interview if they felt uncomfortable or unwilling to continue. The interviews were conducted in an appropriate and peaceful setting within a teaching hospital or school of nursing with respect for the subjects’ privacy. After obtaining the participants’ permission, the interviews and sessions were recorded. All the audio and video recordings from the focus group discussions and interviews were only accessible to the researchers.

The familiarity and professional involvement of the first researcher in the research setting for more than 20 years and the researchers’ long-term engagement and allocation of time for data collection helped gain participants’ trust and thus enriched the data. The research team reviewed, analyzed, and categorized all the codes until the codes, sub-categories, and main categories were identified to increase data credibility. The extracted data were then reported to the participants to examine whether they conformed to their experience, and the necessary corrections were applied. Numerous data collection strategies, such as discussions in focus groups and semi-structured interviews, helped enrich the data. The external observer method was used to confirm the dependability of the data. Two nursing professors outside the research team who were experts in qualitative research were given excerpts from the interview and group discussion transcripts and examples of the process of extraction of the preliminary codes, categories, and sub-categories to examine and give their feedback; their suggestions were applied, and the procedure was thus confirmed.

The first cycle

Tables  3 and 4 present the demographic of the participants. Table  5 shows the frequency distribution of students’ views on the clinical education state of the MNH course before the change.

A total of 680 initial codes were obtained from the analysis of the thirty interviews. Reviewing the initial codes and categories led to extracting three main categories. Table  6 presents the main categories and subcategories.

Unsystematic curriculum and its inadequate monitoring

This category included the following subcategories: Inappropriate curriculum, unstructured evaluation, and trainer inefficiency. An 8th-semester student discussed the inappropriate curriculum due to the big gap between theoretical lectures and clinical training:

“ We studied the theoretical topics three or four semesters ago and could not remember when we finally went to the ward. It would have been better if we had been reminded of some lectures before entering such sensitive wards as the neonatal and maternity ward ” (N: 20).

The ward head nurse said about the students’ lack of mental and psychological readiness:

“ As soon as they enter the ward and encounter an abnormal infant , they get frightened ” (N: 28).

Regarding the lack of information about the training objectives, an 8th-semester student argued:

“ It is not clear what we are supposed to be doing in the ward. Every day is the same and ends the same way. Our goals are unclear during the internship ” (N: 19).

About a large number of students in the internship groups, a trainer argued:

“ We would take a large number of students to the ward , and that did not have a good effect on training , such that I was unable to provide training to all the students during the day , and sometimes the students were even missing from my sight , and that means the waste of the day for the students ” (N:30).

Regarding the lack of monitoring by the school, a student explained:

“ During the time we were in the maternity ward , we were not monitored , neither by the school nor by the hospital , and so we could not discuss our problems ” (N: 16).

A student discussed the lack of transparency in the evaluations and argued:

“ It is not clear at all which item we were assessed on. For instance , we were all the same at work , but the scores were widely different , or vice versa. The trainer gives scores in the same range and makes no distinctions between the active and the passive or the disciplined and the undisciplined students ” (N: 4).

Regarding some of the trainers’ outdated information, one student said:

“ The trainers have got to have clinical experience and be scientifically up-to-date for the students to enjoy their internship and be encouraged to learn. I have not experienced this in my internship ” (N: 14).

Inadequate resources and facilities

This category comprised inadequate equipment, inappropriate educational space, and inadequate welfare facilities. About the lack of access to educational facilities in hospitals and maternal and neonatal wards, a trainer said:

“ There is no library or a place with computer and internet access , or the few that do exist are often disconnected from the internet or have problems ” (N: 3).

Regarding the inappropriate educational space and classrooms for the nursing students, a student stated:

“ We had no classrooms for the group discussions and had to stand in the middle of the ward to give our presentations or in the treatment room , where the discussions were frequently disrupted by the personnel coming and going , and this disrupted the personnel’s work and insulted the trainer and us ” (N: 19).

A student discussed the lack of proper welfare facilities for the students and said:

“ We have to wander around during our break. A break is meant to relieve our fatigue , but it only makes us more tired , and then we return. There are also the insults from some personnel , who complain that the students are wandering around the hospital ” (N: 19).

The student’s lack of motivation

This category included the following subcategories: Insufficient interest in the discipline, inadequate competency, humiliating experiences, tarnished identity, inappropriate personal and intra-group relationships, and the personnel’s beliefs about the nursing profession and nursing students.

Regarding the attitude to working with mothers and neonates, a student explained:

“ I have no interest in working with a parturient or a thumb-sized baby and do not think I will ever be working in these wards later on ” (N: 18).

A student revealed a lack of motivation for learning:

“ I have no interest in nursing , and my discipline used to be the computer , and I merely turned to nurse because of career prospects ” (N: 4).

Concerning having missed opportunities for learning as a result of the personnel’s actions, a student commented: “ In teaching hospitals , the personnel does the work themselves very quickly , and the whole work is already done by the time we decide to carry out patient care along with our trainer , and we miss even just observing the procedure ” (N: 1).

About the medical team’s lack of cooperation in training the students, one of the trainers complained:

“ Sometimes the neonatal or maternity personnel and physician say that nursing students should not enter the ward for infection control , while the case is that we sometimes observe [hygiene rules] better than they do ” (N: 11).

As for the students’ and trainers’ poor professional rapport with the clinical personnel, a hospital nursing director explained:

“ Sometimes , the students do not have any respect for ethical and professional issues. For instance , they do not introduce themselves or exchange greetings with the personnel. They are in the ward for a few hours without the head knowing what they are planning to do ” (N: 7).

The training supervisor discussed the personnel’s interferences in the trainers’ and students’ work and said: “ Some ward heads do not allow the students or trainers to perform certain care measures , such as inserting an IV LINE ” (N: 15).

A student described a nurse’s hostile attitude and improper behavior toward her. She said: “ The personnel did not treat us properly in the maternity ward , as if we were unwanted extras. They constantly threw words at us and nagged us , ‘do not stand here , ‘do not do this , ‘do not touch that , ‘stand aside , ‘Do not block the way !” (N: 1).

Regarding the discrimination made between the medical and nursing students, a student said:

“ They do not allow me to sit in the nursing station , but the medical students easily use the station to review the records and take a break ” (N: 19).

A graduate midwifery trainer stated that the students consider some care procedures trivial:

“ Nursing students feel like taking VS is a low-level task , and they feel disrespected when you ask them to do it ” (N: 17).

One of the nurses also discussed how the students trivialize specific care tasks:

“ Most students are disinterested in primary maternal and neonatal care and prefer to perform invasive or medical procedures ” (N: 26).

Following the evaluation of cycle one, the strengths and weaknesses of the implemented changes were determined (Table  2 ).

Frequency distribution of students’ views on the clinical education state of the MNH course after the change presents in Table  5 . In cycle 2, changes were planned and implemented based on recommendations (Table  7 ).

The final evaluation results after implementing changes on two occasions based on the focus group interviews showed that the unsystematic curriculum changed to a relatively systematic and satisfactory one, the inefficient trainer became more effective, the poor interactions became reasonably solid, and the poor evaluation became efficient. The student’s lack of motivation was replaced with motivation and interest in working in maternal and neonatal wards.

Two of the students participating in the focus groups commented on the systematic curriculum:

“ Just the fact that a logbook was prepared and we , the trainer and the personnel , learned our job description at the beginning of the internship , that the trainers’ , personnel’s , and student’s expectations from each other became clear , these truly abated my stress about doing something that violates the rules and regulations and being penalized for it ” (F2 and N5,1).

One of the participating trainers also discussed the somewhat appropriate interactions formed as a result of the reduced size of the educational groups:

“ The number of students was decreased , which enabled me to communicate more effectively with the students and the personnel. I had more opportunities for teaching too. Due to the reduced number of students , the physicians’ and personnel’s cooperation also grew , and there was no longer any nagging by the physicians and nurses. They even allowed the students to be present during the physicians’ visits and medical procedures” (F1 and N3).

One participant commented:

“ The implementation of this method was perfect because it allowed us to observe the case and at the same time carry a search on our cell phone , because it [i.e. , the material] stuck better in our memory and we were no longer forced to study it at night with all that fatigue just to fulfill a duty” (F2 and N4).

One of the students commented on motivation and interest and said:

“ When the physician allowed us to be present in the visits and tried to engage us and asked questions about the infant and his status and asked what procedures had to be carried out for the infant , I felt proud of myself , as if I was part of the medical team and contributed to the care given , and this made me motivated and interested , and so I tried to study and be prepared for responding ” (F1 and N6).

According to the present study, the problems of clinical training in MNH include the unsystematic curriculum and its inadequate monitoring, inadequate resources and facilities, and the student’s lack of motivation (Table  6 ). The absence of a systematic curriculum and monitoring is a problem in clinical training for nursing students, as confirmed by evidence essentially [ 6 , 24 , 25 , 26 ]. Stakeholders developed a specific internship logbook per the participants’ suggestions of this action research to create a systematic curriculum, specify the goals, and offer the students and trainers a job description. The transparency of the students’ job descriptions affects their learning and contributes to proper communication with the personnel. In line with the present study, Schüttpelz (2016) argued that a logbook is a valuable tool to make training goals transparent, facilitate trainer-student rapport, and standardize clinical training [ 27 ]. Another problem discussed in this category was the inappropriate number of students, given the sensitive and vulnerable nature of neonatal and maternity wards as clinical settings. The participants argued that this factor could increase the risk of infection, make the curriculum organization difficult for the trainer, and create tensions between the students, trainers, and medical personnel. Studies have shown that the main barrier to clinical training is the inappropriate number of students in the ward [ 26 , 28 ]. Previous studies have shown that a large training group in clinical settings means reduced feedback and can result in negligence of errors and unethical behaviors and disrupt the quality of training and the student’s success [ 28 , 29 ]. A proposed strategy was to reduce the number of students in the training groups to three to five, which appears more satisfactory for the ward managers, personnel, trainers, and students. This strategy enabled proper interactions between these groups in an indirect form. As the ward became less crowded, stresses abated, and the trainer had more time to spend with the students. Also, the physicians allowed the students to be present in the ward during the medical procedures and visits and involved them in their discussions. Based on the students’ statements, such a strong presence in the clinical setting and no longer being ignored contributed to their self-esteem.

The students were not ready to enter the maternity ward; simulation training was applied to educate them on the stages of childbirth before entering the ward. Jurana et al. (2015) used simulation as an effective active technique for gathering real experience in a controlled and safe environment for students and patients [ 30 ]. This technique has high validity in nursing education [ 31 ] and improves learning, skill acquisition, and dealing with clinical problems such as student overload in clinical settings [ 30 , 32 ].

The inappropriate evaluation system was another challenge in clinical training. In line with this study, Norouzi et al. (2016) also reported improper evaluations by undergraduate trainers and their inadequate knowledge about the assessment domains and the expectations that surpassed the training given as some of the students’ experiences in this category. In their study, the students believed that there were no specific criteria for clinical evaluation and argued that they were always evaluated based on the trainers’ personal preferences [ 24 ]. According to some evidence, the students’ significant problem in clinical settings included the trainers’ evaluation mode and their lack of sympathy and responsiveness [ 13 , 33 ]. Thus evident that the clinical evaluation of students requires a more transparent instrument [ 34 , 35 ]. Based on participants’ suggestions, an evaluation form was placed in the logbook that complied with the students’ job description and training objectives, and the trainers were educated on how to use it.

Trainer inefficiency was another subcategory extracted due to the trainers’ inadequate skills in training (practical and academic), management, communication, student support, and accountability. Studies have shown that insufficient knowledge and experience and the lack of accountability in clinical trainers are the main problems of clinical training for nursing students [ 6 , 25 , 26 ]. Effective clinical trainers make the clinical setting attractive for the students and familiarize them with the spirit of philanthropy, communication skills, and clinical competency [ 26 ]. They serve as role-model for them and boost their self-esteem [ 36 ]. Similarly, de Swardt et al. argued that clinical trainers could contribute to the students’ tendency toward the nursing profession [ 37 ]. According to the participants of this study, the reasons for trainers’ inefficiency were their constant replacement with others in the clinical setting and the late payment of their wages (if not on a fixed salary system). They argued that these factors could lead to the recruitment of inexperienced trainers with horrible work experience.

This study solved this problem by retaining motivated and experienced trainers with adequate knowledge for teaching MNH. Also, a group was formed in one of the web messaging services to promote coordination between the faculty members and clinical trainers. Another solution was to facilitate the timely payment of wages to attract more experienced clinical trainers.

Inadequate resources and facilities were another extracted category. Evidence suggests this problem negatively affects nursing education in different societies [ 10 , 25 , 26 , 38 ]. The lack of equipment is considered the cause of nurses’ disappointment in decision-making, delayed care, and emotional tensions. Adequate medical equipment, resources, welfare, and physical facilities are essential in any clinical setting to acquire good professional skills [ 39 ]. In the present study, the teaching hospitals’ library books were updated with the cooperation of the hospital directors.

Moreover, through the participation of the training authorities of the hospitals, some classes were dedicated to group discussions between the students and trainers. They were also given any medical equipment they desired, whether for the ward’s needs or not. These accomplishments show that clinical training settings already have these facilities and can provide them to those seeking them. The key to taking advantage of these resources is to request them. The present study facilitated these requests and encouraged the group’s participation in the distribution of resources.

The student’s lack of motivation was another extracted category. The lack of motivation among students at the MNH unit was caused by their lack of interest and desire to learn, lack of clinical qualification, damaged identity, and traditional beliefs about the nursing profession and students. According to Valizadeh et al., students choose nursing more than other fields due to job opportunities, which can result in a lack of focus on the career goals [ 40 ]. Providing a sense of belonging is a crucial mission of higher education institutions, especially in the sensitive and vulnerable parts of MNH. This necessitates a committed and skilled instructor based on evidence, as well as the hiring of experienced instructors and a suitable educational atmosphere [ 41 ]. The student’s feeling of acceptance, being valuable, and belonging are all impacted by the positive communication between the nurse and the student [ 42 , 43 ]. Students who lack a positive professional identity will suffer from lower self-confidence, weakened clinical reasoning skills, and difficulties in establishing interpersonal communication. Their sense of belonging to the nursing profession decreases, their motivation to learn decreases, and they will be less flexible and efficient in dealing with care challenges. Evidence suggests that enabling the students to find their role model can help eliminate their disappointment, disinterestedness, and lack of motivation [ 41 , 44 ]. As a result, this study used fixed trainers with adequate skills to reinforce professional values and make the clinical experience more attractive for the students.

The inappropriate cooperation of clinical nurses and medical teams was another reason for the student’s lack of motivation. One of the objectives of undergraduate nursing curricula is to prepare the students and increase their self-esteem to provide quality healthcare services and cooperate with the care team [ 46 , 47 , 48 ]. Cooperation between healthcare providers and universities is essential for preparing the students to assume their nursing role [ 49 ] smoothly, engage in socialization and adopt professionalism [ 48 , 50 ]. The lack of mutual understanding removes the possibility of close and empathetic relationships and turns the students’ period of presence in clinical settings into a bitter and futile experience [ 45 ]. In this study, the strategy used to solve this problem and create a suitable clinical environment was to familiarize clinical nurses with their job description in training hospitals by holding educational workshops. Also, holding a coordination meeting to familiarize the trainers and students with the concept of logbooks, uploading it on website, posting job description and goals on an educational board in the clinical setting were considered important (Table  2 ). Another solution was for the school or hospital to devise an annual incentive scheme for that clinical and medical personnel who effectively engaged in student training.

Another challenge that deprived the nursing students of motivation was inappropriate communication and poor treatment on the part of the training and medical teams, which included an array of humiliating experiences and a tarnished identity. In the learning process, nursing students often face problems in their professional identity [ 37 ]. Studies have shown that the student’s energy is partly consumed by the challenges and conflicts of dealing with the clinical personnel and believed that the medical personnel does not accept the students as a group member [ 6 , 26 , 45 ]. The students’ positive and negative experiences and attitudes toward clinical practice depend on the relationship between the training and medical teams [ 46 , 50 , 51 ]. Negative communication and behavioral and verbal aggressions projected onto the students from the trainers and nurses can cause stress and a sense of inefficiency and incompetence in the students and adversely affect the formation and development of their professional identity [ 52 ]. Students with a tarnished professional identity will have lower self-esteem and experience problems in their interpersonal relationships, sense of belonging to the nursing profession, and clinical reasoning skills. Inevitably, their motivation for learning will be diminished, and they will be less flexible and efficient when faced with care challenges [ 53 ]. The strategy to solve this problem was to hold educational classes for the personnel, trainers, and students on communication, professional commitment, and ethics. Also, frequent meetings were held between the maternal and neonatal group, the head nurses, and training supervisors to discuss training problems, provide solutions, and create harmony between training and the treatment goals.

In the second cycle, the students assisted in promoting the rigor and fairness of the evaluation (Table  7 ). For this purpose, the students completed an evaluation form for themselves and their classmates. The mean of the student’s self-score, her classmates’ given score, and the trainer’s score were calculated as the student’s final score. Students should have an active role in their evaluation, and if this involvement is achieved correctly, they can better understand their expectations and identify their weaknesses and strengths [ 26 ]. The participants also noted the need for creative and critical thinking and clinical decision-making in these evaluations. Nursing education should frequently improve students’ critical thinking, problem-solving, and decision-making skills [ 54 ]. Studies have shown that modern evaluation methods significantly generate creative thinking, meaningful learning, and clinical decision-making [ 55 , 56 , 57 , 58 ]. Conceptual maps and triple jump assessment were used based on participants’ suggestions; through these tools, the students observe a case, research it on their cell phone or in library resources, and present it in class form. Since evaluation was used as a tool for learning creative thinking, this action resulted in more excellent trainer and student satisfaction from the evaluation. The evidence shows that using conceptual maps in nursing education helps improve education [ 59 , 60 ]. Also, a critical and accessible element for making decisions about patient care is the transparent and judicious use of evidence, which Triple Jumps provides [ 61 ].

A strength of this study was the participation of all the stakeholders, including executive managers and officers of treatment and training, professors, trainers, students, head nurses, and training supervisors, which resulted in a deeper understanding of the existing problems and the offering of more practical and accessible solutions with minimum financial costs.

The study limitations included the absence of male students among the participants because male nursing students need to pass clinical training in MNH and instead take clinical training in emergency nursing services. To strengthen the male students’ skills in providing emergency maternal and neonatal care, simulation was used instead of clinical training, and topics including natural childbirth, neonatal resuscitation and examination, and neonatal ward equipment were trained in practice to male students in the clinical skills laboratory.

The quality of clinical training in MNH among nursing students was improved so that the trainer’s performance in dealing with the student improved. The monitoring and evaluation by education managers and healthcare workers have reached favorable conditions. According to the results, in MNH clinical training, communication skills should be improved, and periodical workshops should be held for the personnel to cooperate with the training staff. Reducing the number of students in educational groups is a key way to enhance education quality, regardless of the financial cost. Also, ongoing interactions among the training and treatment authorities, the participation of competent nursing personnel, and providing a supportive clinical environment for training can help improve the students’ professional and clinical skills. Improving training can also be accomplished by ensuring that the education authorities and professors continually engage in action research activities. Continuous efforts towards quality education should not be hindered by economic problems. If managers are convinced that the quality of nursing services and the role of this group in prevention and health education are important, the mindset that clinical education is the most expensive part of education will be replaced with an investment in the health society. In case of lack of financial ability, training by simulation method, use of new learning and evaluation methods, and use of trainers with high communication skills and aware of the supporting role and counseling and adherence to ethical principles and professional commitment will improve the clinical education of the MNH course. To improve the quality of education, it is important to revise the educational curriculum and increase the unit of MNH in a coherent way, at least in the form of two units, while also paying attention to cultural and gender issues as solutions.

Data availability

The datasets generated and analyzed during the current study are not publicly available due to confidentiality but are available from the corresponding author at reasonable request.

Abbreviations

Maternal and Neonatal Health

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Acknowledgements

This article is part of a nursing Ph.D. thesis. The authors’ gratitude goes to the participants who significantly contributed to this study with their participation.

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F.G., N.D., and A.S. were responsible for the study conception/design. F.G., F.V., and T.T. performed the data collection. F.G. and F.V. analyzed and interpreted the participant’s data. F.G., F.V., and S.H. were significant contributors to writing the manuscript. All authors read and approved the final manuscript.

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The Ethics Committee approved the present study of the Deputy for Research and Technology of Tehran University of Medical Sciences (2212.1396.REC.FNM.TUMS. I) and performed by the Declaration of Helsinki. All the participants were informed of the study’s objectives and were free to express or withhold information. The duration of the interviews was set based on their physical and psychological states. They were reminded that they could end the interview if they felt uncomfortable or unwilling to continue. The interviews were conducted in an appropriate and peaceful setting within a teaching hospital or school of nursing with respect for the subjects’ privacy. The interviews and sessions were recorded after obtaining the participants’ written informed consent. All the audio and video recordings from the focus group discussions and individual interviews were only accessible to the researchers.

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Hoseini, A.S., Ghasemi, F., Valizadeh, F. et al. Improving the quality of clinical training in maternal and neonatal health in undergraduate nursing students: a participatory action research. BMC Nurs 23 , 647 (2024). https://doi.org/10.1186/s12912-024-02160-z

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Received : 05 February 2023

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DOI : https://doi.org/10.1186/s12912-024-02160-z

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