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The Pathway to Becoming a Clinical Research Associate

Introduction to a Clinical Research Associate Career

The role of a clinical research associate, essential skills for a successful cra, certification and education requirements, clinical research coordinators (crc) and clinical trial assistants (ctas), entry-level cra positions, career progression in research, clinical trial project manager (pm) or clinical trial manager (ctm), clinical trial it specialist, conclusion and future trends in cra careers.

The clinical research enterprise supports the discovery of novel therapies, interventions, and diagnostics in many therapeutic areas and applications. Driven by technological enhancements and gains in precision medicine, clinical research professionals are in high demand. Speculative reports indicate the clinical trial market will reach over 70 billion dollars by 2028. [1] With concerns over the anticipated shortages of clinical research associates (CRAs), there are many training options available to choose from.

CRAs can expect to make between 60K and 120K+ per year, depending on a combination of experience, job requirements, location, and education. Individuals may seek employment opportunities from pharmaceutical companies, contract research organizations (CROs), and the federal government. Since they are part of the enterprise of improving patient outcomes, most find their careers in clinical research highly rewarding.

The primary work of a clinical research associate (CRA) consists of monitoring the activities of a clinical research site. Their scope of responsibility also includes facilitating communications between sponsors and research sites, ultimately helping a clinical study reach a successful completion.

A CRA is tasked with overseeing the implementation of a clinical trial protocol in a manner that prioritizes patient safety and data integrity. Specific activities include monitoring:

• Subject recruitment
• Subject screening and enrolment
• Adherence to Good Clinical Practice
• Generation of complete and accurate documentation
• Recording of study data into case report forms and electronic data capture systems
• Study site management

CRAs serve as the nexus among key study stakeholders, such as pharmaceutical companies, principal investigators, clinical research coordinators (CRCs), and clinical data managers. They are core facilitators in the production of the scientific data essential to the development of life-saving diagnostics and therapeutics. [2]

Becoming a successful CRA typically begins with an interest in clinical research. It is common for individuals who enjoy fast-paced work environments, critical thinking, and helping others to choose a research career.

Successful CRAs demonstrate above-average communication, problem-solving, and organization skills. Industry veterans also tend to display a natural tendency towards empathic-based leadership qualities and the ability to work well under pressure.

The CRA is often in charge of multiple study sites. Subsequently, a clinical study professional should be comfortable with travel and demonstrate a high level of computing proficiency to manage substantial amounts of reporting and documentation.

Complementary skillsets that can contribute to the success of a CRA include:

• A comprehensive understanding of activities related to early drug discovery through commercialization
• Advanced medical or scientific knowledge because study data features complex medical terminology, statistical elements, and medical procedures
• Advanced writing abilities to handle the high density of communications
• Well-developed project management skills

Most CRA positions require a bachelor’s degree in life sciences or related fields and a healthy amount of clinical study experience. Several universities offer graduate certificates or master’s degrees in clinical research or clinical trial management. Obtaining a CRA university credential consists of meeting specific eligibility benchmarks determined by educational background, hours of CRA-related experience, letters of recommendation, and industry-specific training records.

Two industry associations offer professional credentials through certification exams. In order to sit for the exam, an aspiring CRA needs to have completed extensive hours working in the field.

The roadmap to obtaining a CRA certification from the dominant professional society mandates the following requirements and benchmarks [3]:

• A minimum of a bachelor’s degree in a life science-related discipline and 3,000 hours of work in human subjects research
• Or an undergraduate or graduate degree (excluding graduate certificates) in the field of clinical research plus 1,500 hours of work in human subjects research
• And an advanced knowledge of applicable regulations, Good Clinical Practice guidelines, and HIPAA requirements

It should be mentioned that professional association credentialing is not necessary to work as a CRA, although some find certification helps obtain employment in certain circumstances.

Career Pathways and Advancement

As with many chosen career paths, the journey to becoming a CRA is not necessarily linear. Many successful CRAs find that training as a CRC allows for greater industry experience and a more fluid transition into a prominent CRA role. A CRC, and sometimes a research nurse, helps conduct a clinical trial and typically works at one site. The transition to a CRA requires a shift in perspective from one who conducts the trial to one who monitors those who conduct trials at several sites.

Alternatively, CRAs may begin their careers as clinical trial assistants (CTAs). CTAs assist with eligibility assessments, personnel management, and participant needs. They also oversee some of the clinical site’s daily functions, which may include correcting safety hazards, maintaining HIPAA and compliance records, and ordering supplies.

Entry-level CRA positions provide a fantastic opportunity to gain more field experience. To help hone their understanding of what is expected, it is common for entry-level CRAs to work alongside other senior members or clinical trial leads.

Hallmarked by extensive administrative and scheduling duties, research data generation and recording, subject recruitment and retention, and determination of study eligibility, entry-level CRAs should learn all the functions that coincide with a clinical trial. Other job functions entail understanding the U.S. Food and Drug Administration’s (FDA) regulatory requirements for clinical research and product market approval.

There are many lucrative management-level opportunities for senior-level CRAs. Most positions require a minimum of a bachelor’s degree. However, some higher-paying jobs may require candidates to have a master’s or doctoral degree, along with a strong record of accomplishment and qualifying experience. CRAs who enjoy mentoring others may also find that exploring training-type positions may provide new opportunities.

Related Career Opportunities in Research

A person in one of these roles is in charge of planning and overseeing the functional details of clinical trials. Working directly for a pharmaceutical company sponsor or CRO, a PM or CTM organizes the personnel, resources, and conduct of research, from initial trial design through study closeout and the final analysis of trial data. The PM or CTM is also responsible for study site management, data capture, analytics, monitoring, validation, and reporting results.

Pivotal to the applications needed to fuel the trend toward decentralized clinical trials, the clinical trial IT specialist is responsible for maintaining the systems used to conduct participant activities and gather study data. This includes optimizing user interfaces for digital functionality and multi-device capabilities. The IT specialist is often responsible for overseeing the integration of electronic data capture systems and maintaining systems used for clinical data analysis. The clinical IT specialist also represents the first line of defense against patient privacy violations, system threats, and HIPAA violations. [4]

Fueled by the need for improved outcomes, we can expect more innovations to emerge from the research sector in the years ahead. There is also a growing momentum to bring more inclusive trial experiences to marginalized populations. Catapulting off an already robust climate, the demand for clinical research professionals will increase significantly. The high demand could dictate the way that the clinical trial industry approaches staffing decisions by hiring based on specific proficiencies.

Current trends hint at a bolder convergence between real-world data and artificial intelligence that may result in improved predictive disease modeling, clinical decisions, and drug optimization. [5] Algorithmic-based capabilities also carry the potential to inform recruitment strategies by removing some of the barriers that impede participation, thereby improving patient diversity.[6] These trends will shape the future of CRA work, thereby demanding that CRAs stay abreast of changes in how clinical trials are designed and implemented.

With so many revolutionary changes to the medical and clinical trial landscape, there has never been a more exciting time to join the research community. Learn more about CRA opportunities today.

1. Markets and Markets Clinical Statistics. Clinical Trials Market Statistics . Accessed June 17, 2024

2. Kandi, V., & Vadakedath, S. (2023). Clinical Trials and Clinical Research: A Comprehensive Review . Cureus, 15(2).

3. Association of Clinical Research Professionals. “ ACRP-CP Certification .” Accessed June 17, 2024.

4. He Y, Aliyu A, Evans M, Luo C. Health Care Cybersecurity Challenges and Solutions Under the Climate of COVID-19: Scoping Review . J Med Internet Res. 2021 Apr 20;23(4): e21747.

5. Harrer, Pratik Shah, Bhavna Antony, and Jianying Hu. Artificial Intelligence for Clinical Trial Design . Trends in Pharmacological Sciences 40(8):577-591. Accessed June 17, 2024

6. Kurt, A., Semler, L., Meyers, M. et al. Research Professionals’ Perspectives, Barriers, and Recommendations Regarding Minority Participation in Clinical Trials . J. Racial and Ethnic Health Disparities 4, 1166–1174 (2017)

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Clinical Research Associate Jobs

Our clinical research associates (cras) are at the heart of our success.

CRA’s work closely with pharmaceutical companies, clinical contractors and hospitals, ensuring adherence to regulations and principles from phases II-IV of a clinical trial. Our CRAs are at the core of everything we do at ICON. They work closely together with our customers to tackle complex issues that can improve the health of patients and the care they receive. 

CRAs are often referred to as Monitors and this is the key difference between a CRA and a clinical research coordinator (CRC). While CRAs are responsible for overseeing a trial and ensuring compliance, CRCs see to patient consenting, identifying patients and reporting adverse effects in clinical trials.

Browse our available Clinical Research Associate Jobs below, or sign up for alerts to be notified when suitable vacancies arise.

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How to Excel as a CRA

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What role will a CRA play in future Clinical Trials?

Becoming a CRA at ICON: Cissy's Story

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We are currently seeking a Clinical Research Associate II Specialist to join our diverse and dynamic team. As a Clinical Research Associate II Specialist at ICON, you will play a pivotal role in desig

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We are currently seeking a Senior Clinical Research Associate to join our diverse and dynamic team. As a Senior Clinical Research Associate , you’ll work within a large-scale, fast-paced environment a

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As a CRA based in the Netherlands you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

2024-112228

As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out inve

2024-110992

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We are currently seeking a Clinical Research Associate to join our diverse and dynamic team at ICON Plc. As a key member of our research department, you will be responsible for overseeing and coordina

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Scientists, researchers, and doctors make discoveries about drugs, surgical procedures, behavioral therapies, or medical devices through their work in laboratories and healthcare settings. This is only the beginning of the journey for pharmaceuticals, therapies, and devices, as bringing the findings from the lab to the street requires a vigorous scientific process known as a clinical trial. Clinical research associates (CRAs) are the professionals responsible for ensuring that clinical trials move forward following established guidelines and regulations for ethics, safety, and reporting.

Clinical research associates, also known as “monitors,” work on behalf of sponsors funding clinical trials for the new or existing drug, device, surgery, or behavioral intervention. Working directly for the sponsor or through a contract research organization, the main task of a CRA is to monitor the progress of an ongoing clinical trial.

Through in-person site visits or remote monitoring systems, a CRA serves as the central point of contact between a sponsor and testing sites; ensures that the trial is being administered per approved protocols; verifies that the clinical trial is being conducted ethically at all sites; and confirms the validity and accuracy of all data being collected and reported at test sites.

In addition to reading, interpreting, and understanding medical technology, clinical research associates must have excellent interpersonal and communication skills. The ability to understand best clinical practices, design protocols, and data standards requires CRAs to have outstanding attention to detail, analytical skills, and the capacity to deliver constructive feedback to participating research sites on their performance.

Although not a requirement, many CRAs travel between multiple research sites for study oversight, which may require a valid driver’s license, the physical capacity to travel, and/or willingness to fly or drive regularly.

This detailed guide explores the education and credentials required to become a clinical research associate (CRA).

Arizona State University

Johns hopkins university (aap), university of west florida, steps to become a clinical research associate (cra).

The pathways to becoming a clinical research associate are numerous and available to anyone with a high school diploma or higher. While formal education is not technically required to enter the field, having a bachelor’s degree or higher can make potential candidates much more competitive.

Certification in the field is also not required, but obtaining certification from the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP) can result in more opportunities and even more competitive salaries.

Finally, all aspiring CRAs are advised to check out the International Conference on Harmonisation’s (ICH) guidelines for Good Clinical Practice (GCP) to get a feel for the professional expectations and responsibilities.

Here is how to become a CRA depending on one’s level of education. Please note that in the United States, there are two major certification bodies for CRAs: the Society of Clinical Research Associates (SOCRA) and the Association of Clinical Research Professionals (ACRP). Each pathway includes the eligibility requirements to pursue credentialing through either of these entities.

PATH 1: Earn a High School Diploma and Gain Experience

Perhaps the most strenuous route to this career is becoming a certified CRA with a high school diploma and between 3,000 and 3,500 hours of qualifying work experience (depending on the certification entity).

These candidates often start out in support positions assisting a more experienced or certified CRA with mundane tasks. An entry-level worker can earn increased responsibilities through a demonstrated capacity to learn the regulations, protocols, and ethical considerations. To qualify for the following CRA certification exams, high school graduates must:

SOCRA Category 1

• Complete two full-time years of CRA work within five years, or 3,500 hours of part-time work

ACRP CCRA (Certified Clinical Research Associate)

• Complete 3,000 hours performing essential duties
• Submit a resume documenting and demonstrating job performance

Please note that in some cases, additional education can be used to substitute for work experience hours. Please see credentialing websites for details.

PATH 2: Earn an Associate Degree and Gain Experience

Depending on the program, an associate’s degree of applied science (AAS) in clinical research can be a standalone degree or a stepping-stone to a bachelor’s or master’s. Licensed vocational or practical nurse (LVN or LPN) programs are designed specifically for practical, job-ready skills and may qualify aspiring CRAs for the ACRP certification.

Similar to the path taken by those with a high school diploma, having an associate degree, LPN, or LVN can open the door to some entry-level jobs in the industry. At this level, some prospective CRAs assist more experienced CRAs or some engage independently in entry-level tasks related to study monitoring. Those working as CRAs with an associate’s degree, LPN, or LVN can qualify for certification after working a certain number of hours in the field.

To qualify for the following CRA certification exams, associate degree graduates must:

SOCRA Category 2

• Hold a “clinical research” degree
• Complete one full-time year as a CRA or 1,750 hours part-time

ACRP Option 2 (Also for LVN, LPN)

• Hold a “clinical research degree” or complete 1,500 hours performing essential duties

PATH 3: Earn a Bachelor’s Degree and Gain Experience

Most entry-level clinical research associate positions require candidates to have a bachelor’s of science (BS) in a health-related field from an accredited four-year university. In some cases, programs are designed to add practical hours needed to qualify for certification tests.

Those interested in becoming a CRA can study nursing, health sciences, biological sciences, clinical research, clinical research administration, clinical research management, medical technology, or life sciences, among many other subjects. Because many entry-level positions are looking for those with previous work in the field, those earning a BS should seek internships, part-time work, and/or fellowships involving participation in research, if possible.

To qualify for the following CRA certification exams, bachelor’s degree graduates must:

SOCRA Category 3

• Hold a “clinical research” undergraduate degree

ACRP Options 1 & 2

• Complete 3,000 hours performing essential job duties or 1,500 hours of equivalent work experience requirements through ACRP certifications or approved clinical research degree programs accredited by the Council for Higher Education

PATH 4: Earn a Master’s Degree for Opportunities in Management

A master’s program in clinical research is generally designed for those already working as CRAs to expand their skills or to advance into management or supervisory roles within the field. However, for those with non-health science bachelor’s degrees who want to become CRAs, seeking a master’s of science in clinical research or a master’s of science in clinical research management could be a pathway to breaking into the field.

Because many of these programs are offered online, earning a degree is possible for even those students who need full flexibility of schedule to complete the degree. Although requirements for admission into master’s programs vary, those looking to gain admission into a master’s of science for clinical research commonly need the following:

• A bachelor’s degree
• Official transcripts demonstrating specific coursework in science
• A statement of purpose
• Letters of Recommendation or Reference
• A resume or CV
• An application fee
• TOEFL or IELTS scores (international students only)

Clinical Research Associate (CRA) Degree Programs

There is a range of formalized training programs that prepare professionals for this key role in ensuring the safe, and ethical development of medical technologies. Below you will find examples of programs at a range of educational levels available to those interested in a career as a CRA.

Durham Tech – AAS Program

Durham tech, located in Durham, North Carolina, offers a 71-credit hybrid on-campus and online clinical trials research associate (CTRA) associate of applied science (AAS) program. Durham’s CTRA AAS prepares graduates to work on any side of clinical research in an assistant’s role.

While most programs require the student to attend on-campus courses, there are several courses that are offered completely online. The program takes 20 to 21 months and includes coursework in research site management; clinical research management; research protocol design; an introduction to ethics; anatomy and physiology; an introduction to clinical data; pathophysiology; and clinical research terminology.

Graduates of the program may be eligible to sit for national certification examinations and will be prepared for opportunities at medical centers, pharmaceutical industries, hospitals, research facilities, clinics, physicians’ offices, and device companies.

• Location: Durham, NC
• Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC); Commission on Accreditation of Allied Health Education Programs (CAAHEP)
• Expected Time to Completion: 20 to 21 months
• Estimated Tuition: $5,396

Washington University in St.Louis University College – BS, MS, Certificates

Washington University in St. Louis, Missouri, has various degree options for CRAs at all stages of their career to work as monitors. Students can enhance their current skills and knowledge in clinical research management, as well as gain a deep mastery regarding how to best move clinical research forward in an ethical, compliant, and safe way.

Those with at least six units of transferable coursework qualify to apply to the 120-credit-hour bachelor of science in clinical research management to start their careers. Anyone with any educational background can pursue University College’s 21-credit undergraduate certificate in clinical research management to enhance career skills or make a resume more competitive.

Students who already have a BA or BS also have options at Washington University. Experienced professionals in the clinical research field who wish to seek formalized training can earn a 21-credit advanced certificate in clinical research management or a 30-credit master of science (MS) in clinical research management. Those with a non-healthcare bachelor’s degree who wish to become high-level CRAs can up their skills and knowledge by choosing the combined bachelor’s and master’s degree options.

Although the coursework in each program varies to suit the level of education, themes across all the programs include the fundamentals of clinical research management; research ethics and regulatory affairs; compliance, legal and regulatory issues; and data and information management in health sciences.

• Location: St. Louis, MO
• Accreditation: Higher Learning Commission (HLC)
• Expected Time to Completion: BS (up to 48 months); certificate (12 months); MS (24 months)
• Estimated Tuition: Undergraduate courses ($695 to 895 per credit); Graduate courses ($665 to 995 per credit)

Barnett International – Online Seminar

Designed for CRAs with two years of experience or less, this online clinical research associate onboarding program by Barnett International prepares entry-level employees to monitor clinical trials at high levels appropriate to industry standards.

Over ten weeks of synchronous online coursework lasting three hours per week, participants will learn topics including informed consent, investigational product accountability, safety definitions and reporting requirements, and regulatory compliance and quality assurance: audits and inspections. Participants receive 30 hours (3.0 CEUs) of continuing education credits.

• Location: Needham, MA
• Accreditation: Accreditation Council for Pharmacy Education
• Expected Time to Completion: Ten weeks
• Estimated Tuition: By Early Bird Deadline ($1,795); After Early Bird Deadline ($1,995); June 10 is the early bird deadline

Continuing Education for Clinical Research Associates (CRAs)

Both CRA certification bodies require continuing education to maintain active certification status.

SOCRA requires recertification every three years. It calls for 45 hours of CE to be completed over the course of the first three years beyond passing the initial test. Twenty-two CE units must be related to clinical research; the remainder can be in the professional or therapeutic area in which one works or specializes. In addition, those looking to maintain or renew certification must complete a “recertification continuing competence learning module.”

The ACRP expects certified CRAs to engage in continuing education (CE) and continuing involvement (CI) to maintain certifications. Continuing education should include coursework in research and healthcare, and continuing involvement requires candidates to engage in activities such as authorship, participating in investigator meetings, or working as a peer reviewer, among other opportunities. Notably, ACRP utilizes an ongoing point system for professionals to maintain their certifications.

CRA Career and Salary

Clinical trials and the objectivity they bring to advances in treatment are extremely important. In an increasingly globalized society, diseases spread across borders, and in an age of increased antibiotic resistance, new ways to fight bacteria will be needed. Furthermore, with an aging U.S. population comes increased rates of chronic conditions and the subsequent reliance on pharmaceuticals to improve people’s quality of life.

It’s not surprising that the Bureau of Labor Statistics (2022) predicted a 7 percent increase in openings for medical and clinical laboratory technicians between 2021 and 2031, much more than the average growth anticipated across all U.S. occupations during that same decade (5 percent). As far as the salaries are concerned, here are the salary percentiles for clinical laboratory technologists and technicians in the US ( BLS May 2022):

Lastly, while the BLS doesn’t track salaries for CRAs, PayScale.com (June 2023)—a site that relies on self-reported data—found that the median annual salary for a CRA was $72,393. Among the 1,391 CRAs reporting their annual salaries, Payscale found these percentiles:

• 10th percentile: $48,000
• 50th percentile (median): $72,393
• 90th percentile: $101,000

Specialized skills in CRA that increased salaries included medical devices (37 percent pay increase over average), team leadership (35 percent), and writing procedures & documentation (20 percent).

Years of experience, predictably, also have an impact on salary. Entry-level CRAs earn 15 percent below the average, while experienced CRAs (ten to 19 years) earn 16 percent above the average and late-career CRAs (20+ years) earn 25 percent above the average.

It is important to note that these figures also vary based on the data source. For illustration, Indeed.com (June 2023) found an average annual salary of $80,957 among United States clinical research associates.

Becca Brewer is building a better future on a thriving earth by healing herself into wholeness, divesting from separation, and walking the path of the loving heart. Previously to her journey as an adventurer for a just, meaningful, and regenerative world, Becca was a formally trained sexuality educator with a master of education.

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6 skills to be a successful Clinical Research Associate: #SuccessFactors

6 skills to be a successful clinical research associate.

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On the hunt for a fulfilling career as a clinical research associate here are six essential skills to consider for a successful career path as a cra at iqvia..

At IQVIA, we are tackling some of the biggest challenges in healthcare in pursuit of our mission to accelerate innovation for a healthier world. Our clinical research associates (CRAs) play a vital role in that effort, serving as overseers, conductors and documenters of our clients' clinical trials. 

CRAs at IQVIA are ambitious, passionate and bring a deep level of expertise to solve complex clinical issues while ensuring adherence to regulations and sponsor requirements. An IQVIA CRA’s ultimate goal is to deliver life-changing therapies as fast as possible, but without compromise.

Think this might be the career for you? Here are the top 6 factors to support a successful career as a CRA at IQVIA.

• 1. Communication

As a CRA, you are the key liaison between management, the study site, and the sponsor. With so many moving parts in clinical research, strong interpersonal skills and good command of English are important. It is also critical to have fluency in the local language of the respective country you work in. When difficult conversations come up, you’ll rely on these skills to effectively manage the situation and ask thoughtful questions. 

“Effective communication as a CRA comes down to considering your audience and their unique needs,” said Clinical Functional Service Provider CRA. “As a CRA, you regularly have conversations with healthcare professionals, management and site personnel, all with varying education levels, knowledge and skillsets. It’s important to read the room, know how your audience wants to receive information and pivot based on who you’re talking to.”

2. Relationship management 

A CRA builds relationships with all parties involved in the trial. Much like communication, there are nuances to these relationships. A great CRA knows when to lead versus support, can effectively manage through site-related issues and stays connected to study staff and research sites. 

“Relationship management is a pivotal component of monitoring,” said Senior CRA. “Establishing trust between yourself, as the CRA, and the sponsor and site staff help create a positive work environment for all parties. These relationships are beneficial to study compliance, productivity and collaboration so we can all achieve our end goal to improve patient outcomes.”

3. Attention to detail 

Keen attention to detail while executing site activities — initiation and start-up, recruitment, monitoring, site management and close-out — is critical to the quality and integrity of any study as the smallest error can lead to major consequences. As a CRA, your meticulousness in documenting how you conduct protocols, adhere to applicable regulations and capture site findings and action plans is foundational to the study’s success. 

“Find a tool that works best for you… it can be anything from old fashioned pen and paper, folders, spreadsheets or digital notes…whatever you choose, just be sure to capture everything you and the site have done and still need to do,” said Janet Robinson, senior CRA 3. “We work in an environment where everything is important, and if it’s not documented, it didn’t happen. An acute eye for detail will ensure that you keep accurate and timely notes at every stage. This will help later with time management, too!”

4. Critical thinking

Rapidly changing protocols, low patient recruitment and data errors are the norm in clinical research. As a CRA, you are the decision-maker, and the site team relies on your clinical expertise when it comes to spotting and solving problems. Critical thinking is key. If you spot a site-related issue or error that could impact data or patient safety, chart a course for corrective action. Study protocols, Good Clinical Practice (GCP) documents and operating procedures are all tools to support you in mitigating risk that could jeopardize the integrity of a study or cost the sponsor time and money. 

“Rather than letting adversity get you flustered, reflect on past experiences and use a ‘no time wasted’ approach to influence the outcome of a future project or milestone,” said Clinical Functional Service Provider CRA 2. “Take a step back to evaluate the situation, use your resources, training and past experiences to brainstorm potential solutions, and deliver quickly and compliantly.”

5. Time management

As a CRA, no two days are the same, and you must adapt to an ever-changing environment. A well-trained CRA must be able to effectively prioritize their time and juggle competing priorities across projects and site personnel to ensure the trial is carried out within the appropriate deadlines and within budget. 

As for managing your day-to-day responsibilities, sometimes figuring out where to begin is the biggest problem. Your task list can feel overwhelming, so a simple to do list is a great way to arrange your responsibilities. Rank your tasks by priority and tackle them one by one!

6. Stress management

Being a CRA is not always glamorous. There are long days on the road, rapidly changing protocols and monitoring reports to complete across multiple study sites. Treating patients with drugs for the first time can be stressful for patients and CRAs alike. 

“As a junior CRA, you have done the training, but now it’s time to pull all the pieces together, and that can be a daunting and overwhelming thought,” said Robinson. “Finding a mentor to field questions without judgement can help alleviate some of the stress. At IQVIA, we have a fantastic mentor program to help our CRAs navigate those early days and thrive through their career.” 

Off the job, find your outlet, whether that’s mediation, exercise, reading or spending time with family and friends. IQVIA is a huge proponent of work-life balance. We know you can’t be successful at your day job if you are not taking care of your mental, physical and social health, and we are here to support you to that end. 

What can you expect in return from IQVIA?

Love what you’ve read and think you’re a great fit for a CRA role?   Join us ! IQVIA offers a rewarding career path, compensation structure and development programs for CRAs. Our well-established training programs, access to cutting-edge technologies and the stability of a global organization enables you to have a long-lasting and fulfilling career journey as a CRA at IQVIA. 

“At IQVIA, we are committed to supplying our CRAs with the right tools, training and development support to allow for success and career growth,” said Dan Mink, director, Clinical Operations. “In addition to the rewarding work, collaboration and engaged line management, there is a constant focus on development as your career growth supports also the growth of the company.” 

Take the first step toward a fulfilling CRA career at IQVIA.  Apply to our CRA jobs today.

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Clinical Research Associate: A Full Guide on Becoming A CRA

Clinical Research Associate

A complete guide on how to become a clinical research associate.

Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care.

As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree.

This is why a career as a CRA should be considered with clinical research coordinator training. We train over 500 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).

For those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career.

Because the position is unlike actually working in the lab and more of a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered).

Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year: an amount that is uncommon in other science-degree careers.

CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. T

his is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.

Clinical Research Associate Certification Qualifications

Foreign Doctors Welcome : A Clinical Research Associate or Coordinator plays a vital role in directing and supervising clinical trials conducted by physicians, nurses, and other science professionals. This career path is particularly attractive to many foreign doctors with completed medical degrees (MBBS) who can utilize their expertise in the US healthcare system by pursuing a CRA career instead of taking the USMLE or repeating residency training. For those interested in coordinating aspects, consider the Clinical Research Coordinator course .

Distinct Skillset : Unlike the traditional medical field you may be familiar with after years of schooling, Clinical Research Associate training provides a distinct and valuable skillset. For comprehensive understanding of Good Clinical Practice, see the ICH-GCP course .

Most Extensive Online Course : Our program goes beyond basic introductions, offering a comprehensive curriculum with over 110 modules – the most extensive Clinical Research Associate course available online. This in-depth training ensures you're well-prepared to secure a coveted CRA position.

Superior Coursework : Securing a CRA role is a strategic career move compared to the limitations of many traditional medical positions. While generic courses abound, we've observed that graduates often struggle due to a lack of substantive content. Our Clinical Research Associate course addresses this gap by providing Senior Clinical Research Associate-level training through 110 intensive modules grounded in the latest scientific principles. For those looking to assist in clinical trials, the Clinical Trials Assistant Training may also be of interest.

Diverse Career Opportunities : This high-demand science-based medical field offers diverse opportunities:

Work in the Private Sector : Pursue a CRA career with renowned pharmaceutical companies like Pfizer. Enhance your skills with the Advanced Clinical Research Project Manager Certification .

Academic Opportunities : Work in the academic sphere at medical schools. Those aiming for higher responsibilities may consider the Advanced Principal Investigator Physician Certification .

Unmatched Flexibility and Knowledge : In addition to our exceptional course content, we boast the largest number of clinical research courses available online, providing you with unmatched flexibility and knowledge. For those interested in safety monitoring of drugs, the Pharmacovigilance Certification and Medical Monitor Certification can enhance your capabilities in these critical areas.

Why Take A CRA Certification Course

 The role of the clinical research associate is to ensure that medical devices, new treatments and new drugs are approved for patients' use.

This field is taken as a certificate program course in many schools. For example, you may find associate degree programs. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

If you opt for a fully online program, you can still get an immersive education. Different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as the lecturers.

Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order for students to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

These certificate programs are generally designed for professionals that are already in the medical fields (like medical assistants or nurses) and are interested in moving to the field of clinical research.

They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials.

During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective. The need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience in clinical trials.

Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

In applying for the post of a clinical research associate , ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to.

Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might increase your chances.

Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement

The Best CRA Certification Course For Entry-Levels

There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training.

Our program is considered one of the top clinical research graduate programs online. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts.

Because our modules are prepared help even Senior Clinical Research Associates, we find more of our students with no background quickly passing their interview rounds.

CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail.

After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience.

Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing.

This advantage allows many students with limited experience to get hired with a higher paying job than previously offered.

While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. nonetheless, we train all students at a Senior CRA level regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken.

Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat. Medical knowledge is supplemental but not sufficient in this career path.

This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.

How To Get Experience For Clinical Research Associate Jobs

CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

Always use a cover letter specific for the company and job when applying if you are not using a recruiter.

The ICH-GCP in Clinical Research

Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:

The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).

Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.

One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research. 

Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.

The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.z

Qualifications and Qualities of a CRA

According to the International Accrediting Organization for Clinical Research (IAOCR), candidates for CRA positions usually hold either a biological science degree, or one in medicine or nursing10. 

The New Scientist recommends that aspiring CRAs should possess a good working knowledge of one or more of the following subjects – anatomy, biology, biochemistry, chemistry, immunology, microbiology, pharmacology, physiology or toxicology11.

In addition to a background in medical or life sciences, a CRA is required to have a good grasp of data management, including Electronic Data Capture (EDC), data analytics and reporting12.

Sketching the CRA work profile, the authors Diane St. Germain and Marjorie Good state that CRAs are the ones who scrutinize clinical study data most closely from start to finish—as a result, they are often the first to notice critical patterns and interesting trends, and to report these to the research team as well as to the CRO13.

Equally if not more importantly, a CRA must possess a high level of emotional and interpersonal savvy. This is a crucial area, since a CRA’s success hin ges upon his/her ability to elicit the best from team members, in terms of both performance and probity. 

Core Competency Framework for CRAs

To illustrate, the ACRP’s ‘Core Competency

Framework for Clinical Study Monitoring’

requires that a CRA should be able to identify

and correct compliance violations at a study

site. The CRA must not only bring such

violations to the attention of site staff, s/he

must induce them to take corrective action,

as well as reporting the matter and even

escalating it, where necessary14.

The table below summarizes the ideal

competencies of a CRA, and provides

insights on how each ability contributes to

the CRA’s performance.

CRA Career Path

In the past, CRA positions were often filled by individuals with medical or nursing backgrounds, with little thought given to their lack of research training15. As awareness grew about the importance of research experience for a CRA, employers began preferring those with years of experience in clinical research settings, such as Clinical Trials Assistants (CTAs) and Clinical Research Coordinators (CRCs)16.

However, in recent years, the focus has shifted once again from a tenure-based mindset to a skills-based evaluation17. In part, this change has been brought about by the growth in professional courses and training programs in the field. 

For instance, many leading US Universities today offer master’s programs in clinical research18. In addition, there are some widely recognized certification programs for clinical research associates, such as those offered by the ACRP19 and the Society of Clinical Research Associates (SOCRA) 20.

Note: You must already be working as a CRA to qualify for the ACRP and SOCRA certification programs.

A Toe in the Door: CRA Certification for a Non-CRA

By this point, you might be wondering, “I have no research experience… I’ve never worked as a Clinical Trials Assistant (CTA) or a s a Clinical Research Coordinator (CRC). Nor do I have a degree in Clinical Research. Can I still become a CRA?”

The simple answer is, yes, you can.

You might be a life sciences graduate looking for a lucrative career in the pharmaceutical or biotechnology sectors. Or, you’re excited by a career in research, but unsure whether the drudgery of a Ph.D. is your thing.

Maybe you’re just looking for a job that represents a great option for someone with your combo of science background plus detail-orientedness.

Whichever of these descriptions best applies to you, a career as a Clinical Research Associate could be exactly right for you.

With the right training, you can be recruited directly to a Clinical Research Associate position, even without a background in clinical research.

So, what kind of training will help me break through the ‘experience’ barrier and land a job as a CRA?

As you’ve already gathered from the table, the skill-set required to be a successful CRA is pretty extensive.

Aside from an in-depth knowledge of scientific and medical concepts and principles, a CRA must have a sound grasp of medical research regulatory requirements, a penchant for being thorough and systematic, as well as a knack for coordinating and managing people with diverse skills, roles and backgrounds.

To our knowledge, CCRPC’s ‘Advanced Clinical Research Associate Certification’ (ACRAC) is one of a kind: The ACRAC is the only multi-accredited* certification program in the US that offers the kind of exhaustive as well as intensive training that equips candidates from a non-clinical background with the abilities and competencies that make a good CRA.

Best of all? The ACRAC is open to fresh graduates holding a B.S. degree in any of the life sciences, with no requirement for prior exposure or experience in clinical research.

*The ACRAC program offered by CCRPC is accredited to ACCRE (Accreditation Council for Clinical Research & Education), ACCME (Accreditation Council for Continuing Medical Education), ACPE (Accreditation Council for Pharmacy Education), ANCC (A merican Nurses Credentialing Center), as well as Transcelerate Biopharma.

Training to be a CRA through CCRPS ACRAC

The ACRAC program includes over 100 course modules that cover all the important knowledge domains and skill-sets required by a CRA.

Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.

Starting with a broad overview of clinical research jargon and terminology, the course walks students through the principles of Good Clinical Practice, familiarizing you with the relevant sections of the ICH-GCP and the FDA’s E6(R2).

The program places particular emphasis on ethical practices in research with vulnerable populations.

Students going through the ACRAC are trained in all major aspects of designing a Clinical Trial Protocol in keeping with the Code of Federal Regulations (CFR).

They additionally learn the steps involved in the IRB/IEC approvals process and how to prepare required documents.

Finally, students become aware of the importance of pharmacovigilance and the regulatory process for new drug testing.

A major chunk of the ACRAC certification centers around equipping the CRA for day-to-day responsibilities, such as different types of site visits – preliminary (Site Qualification), preparatory (Site Initiation) and progress monitoring visits (Routine Monitoring).

Crucially, the ACRAC covers essential documentation such as the Case Report Form and Trial Master File, as well as electronic data capture (EDC) and remote monitoring systems.

A vital component of the training program involves empowering students to tackle challenging situations.

For a CRA, these include identifying protocol deviations and violations, and recognizing as well as reporting research fraud and ethical misconduct.

In addition to its comprehensive coverage, the ACRAC certification offers the great advantage of including 17.5 CME credits – that is, course credits that count towards ‘Continuing Medical Education’.

These credits can be used by individuals desiring to further their education and/or careers in healthcare-related fields, including medicine, nursing, pharmacy and research.

Clinical Research Associate Training

Get ahead in clinical research with advanced accredited online CRA certification for $450. Demo our on-demand course below.

Clinical Research Associate Certification

Advanced clinical research associate certification (acrac).

Chapter 1: Introduction

This chapter orients you to the concept of Continuing Medical Education (CME) and outlines how the CCRPS CRA program contents meets AMA requirements for CME. Given that, across the US, physician practitioners are required to complete between 20 and 50 hours of CME credits yearly, the ACCME-accredited CCRPS CRA course can be used not only to build knowledge and skills in the field of clinical trial management, but also to further a successful medical career. Additionally, the introductory chapter introduces you to the clinical terminology and abbreviations commonly encountered in clinical research, for example, Investigational Product (IP), Good Clinical Practice (GCP), Institutional Review Board (IRB) and so on. 

Chapter 2: Roles and Relationships in Clinical Trials

The unit presents the foundational background to beginning and building a career as a clinical research associate (CRA). As you know, a CRA plays a critical role in setting up as well as monitoring the clinical trials process for an investigational product or IP – a medical drug or device under development. In this unit, you will learn how a CRA interacts with other stakeholders, including the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC),other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

Chapter 3: Sponsor and Investigator Roles

In this unit, you will gain insight into the ICH-GCP guidelines, particularly addendum E6, sections 2 through 5, which outline procedures and precautions essential for protecting the safety and wellbeing of human research participants during clinical research. These include guidelines for obtaining informed consent from human subjects, maintenance of trial records, reporting of compliance, safety and research progress, as well as procedures for suspension or termination of the trials process. The chapter familiarizes you with the critical importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

Chapter 4: Clinical Trial Design

In this chapter, you will acquire insight into the different phases of the clinical trials process, from the pre-clinical phase through Phases 0 to 4 of clinical testing. The unit will familiarize you with important concepts of clinical trials, such as the structure and goals of each phase of clinical trials, approaches to dosing, toxicology of pharmaceutical products, in vitro and in vivo testing, dose escalation and so on. Finally, the chapter reviews the FDA’s drug approval process.

Chapter 5: ICH-GCP – Overview

The chapter dives deep into GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as  Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

Chapter 6: Ethical Research in Vulnerable Populations

The unit provides a detailed walk-through of the regulations and compliance requirements for conducting clinical trials with human subjects who meet the definition of a ‘vulnerable population’, including pregnant women and fetuses, children, mentally incapacitated individuals (those with cognitive functioning impaired by neurolopsychological conditions or chronic substance abuse), as well as prisoners. You will acquire familiarity with the challenges of research in such populations, including the requirement for parental consent, fair but not excessive incentive, justifiable deception or incomplete disclosure, coercive practices and so forth.

Chapter 7: Adverse Events

Through this module, you will gain a bird’s eye view of the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects. 

Chapter 8: Clinical Trial Protocol

The chapter provides an in-depth tutorial on the structure and elements of a CTP or clinical trial protocol, as well as guidelines on writing a CTP. Important concepts reviewed include study Risk Benefit Analysis (RBA), study sample statistics (sample size, statistical power, plan for data analysis), risk management and study administration. Additionally, the module covers concepts central to study sample selection, addressing inclusion and exclusion criteria, especially safety and ethics considerations in sampling. 

Chapter 9: Protocol Deviations and Violations

Through this unit, you will gain familiarity with the many potential causes of protocol deviations and violations, learning to distinguish between minor (deviations) and major departures or violations of protocol. Content provides understanding of the most commonly occurring violations, including both minor (off-schedule subject assessments, subjects’ use of prohibited drugs, and so on) as well as major violations (failure to obtain informed consent, failure to report AEs and so forth). Further, the chapter reviews principles for reporting protocol deviations, IRB approval for planned deviations and related concepts. 

Chapter 10: IRB and DSMB

This chapter briefly reviews the history of IRBs and examines the principles guiding IRB decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.   

Chapter 11: Review Questions

The module provides a self-assessment tool by including questions that review the content covered in previous chapters. The set of 71 questions examines all aspects of ICH-GCP previously discussed.

Chapter 12: Site Monitoring Visits

In this module, an overview is provided of the different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

Chapter 13: Site Qualification Visit (SQV)

The chapter gives an in-depth understanding of the stages and steps involved in selecting a study site. Elements reviewed within the module include the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). Importantly, the module reviews the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.  

Chapter 14: Site Initiation Visit (SIV)

The module dives into the details of an SIV or site initiation visit. You will review the procedure for pre-SIV preparation, including filing for IRB and other necessary approvals, permits and licenses. Additionally, the chapter examines elements of the SIV agenda, mainly orientation and training of site staff, creation of important study-related documents such as the Trial Master File (TMF) and post-SIV filing of compliance documents such as FDA form 1572 and Financial Disclosure Form (FDF) for relevant site personnel. 

Chapter 15: Routine Monitoring Visit (RMV)

In this unit, the elements of a routine or periodic monitoring visit are discussed in detail. You will become familiar with the agenda of an RMV, which prioritizes receiving updates on AEs from site staff (incidence, documentation, seriousness and so on), as well as oversight of the overall progress of trials. The chapter covers different approaches to site monitoring, contrasting traditional (full-scale) monitoring with risk-based monitoring (RBM), as well as comparing on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is central to obtaining meaningful, high-quality data from clinical trials.

Chapter 16: Site Close-Out Visit (SCOV)

The module gives you a comprehensive overview of the protocol and procedures involved in terminating or closing out a trial site. Aspects covered in the chapter include pre-SCOV preparations such as IRB notification and schedule coordination among site staff (PI, other investigators, medical staff) and monitoring team (CRC, CRAs and so on), agenda for an SCOV – drug inventory management, database verification and lockdown, subject intimation and completion of all subject-related documents, staff-related documentation as well as other administrative tasks including close-out report compilation.

Chapter 17: Tools for Monitoring Visits

This unit outlines a host of tips and tools that can help a CRA in successfully tackling the complex process of monitoring clinical trials. The chapter lists numerous physical accessories you can use for effective monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions. 

Chapter 18: Audit and Inspections

The module deals with one of the most crucial and often most feared aspects of a CRA’s career – audits and inspections by the CRO (sponsor), FDA or other regulatory authority. Starting from the basic distinction between an audit and an inspection, the chapter covers in detail the protocols for both audits and inspections. Crucially, the chapter will enable you to grasp the difference between a routine audit/ inspection and a ‘for-cause’ audit/ inspection. Further, it lays out the sequence of an FDA inspection in full (including a detailed walk-through of the FDA BIMO or Biomedical Research Monitoring Program inspection), and provides important guidelines on the do’s and dont’s for CRAs during an audit/ inspection, such as the critical ‘3 to 5 minute rule’. You will acquire familiarity with important audit and inspection-related documents such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation) as well as the Establishment Inspection Report (EIR) prepared by the auditor/ inspector. Finally, you will gain insight into the classes of observations provided in an EIR, including NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated)—the last is commonly termed an ‘FDA warning letter’.

Chapter 19: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of clinical trial quality monitoring, including monitoring visits, tools as well as audits and inspections.

Chapter 20: SDV and Informed Consent

In this chapter, the ICH-GCP section 4.8 guidelines on obtaining informed consent from subjects are discussed in detail, highlighting the need for using non-technical language, transparent delineation of risks, consent without undue influence, obtaining consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to conform to ICH-GCP requirements that subject trial data (as recorded in Case Report Forms or CRFs) must correspond to source data (previous medical records).

Chapter 21: Case Report Form

The module provides an in-depth tutorial on the structure and elements of a Case Report Form or CRF, including the different forms for PI verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events and so on. In addition, the chapter outlines important data notation rules, such as the use of accepted acronyms (‘ND’ for missing data and ‘UNK’ for unknown information, MM-DD-YY format, time-stamp data and so forth), as well as guidelines for the design of CRFs (such as consistency of notation, avoidance of data fields that can be computed and of duplicate data fields and so on).

Chapter 22: Quality Control and Safety

Within this unit, you will learn the central concepts of Quality Control (QC) in the context of clinical trials, including definitions of QC and its relationship with the complementary process of Quality Assurance (QA), the use of Key Performance Indicators (KPIs) in QC, need for a Corrective and Preventive Action (CAPA) plan and so on. Additionally, the module examines the QA process, focusing on the central role of RBM or risk-based monitoring in present-day QA as well as providing guidelines on Quality Metrics (QMs) for evaluating the trials process. The chapter also reviews ICH-GCP guidelines on subject safety, underlining risk-benefit assessment, stoppage rules (for instance, in case of SAEs) and reporting responsibilities. Finally, it introduces the FDA’s Human Research Protection Program (HRPP) as a platform that provides training and support for personnel involved in clinical trials.

Chapter 23: Technology in Trials

In this chapter, an in-depth tutorial is provided of the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs) including IVRS and IWRS (Interactive Voice and Web Response Systems, respectively) as well as RTSM systems for Randomization and Trial Supply Management are examined.  The unit reviews the benefits of standardized data management and data sharing, approaches to database management and the concept of an Independent Data Monitoring Committee (IDMC). Critical elements of data integrity, such as proper anonymisation and coding, completeness of data, data safety precautions and logging of site visits and other progress reports are highlighted. The unit further examines the essential features of a good Clinical Data Management (CDM) system that complies with FDA CFR Title 21 and HIPAA regulations, such as setting access privileges, tracking changes and updates, data security and locking, flagging and reconciliation of AEs and so forth. Finally, the chapter looks at CTMSs (Clinical Trial Management Systems) in depth, covering the aspects that allow management of day-to-day trials in multi-site studies. 

Chapter 24: Modernized Monitoring (Remote, Risk-based, Centralized)

 This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements. Finally, the unit examines how risk-based monitoring approaches have allowed centralized monitoring to evolve into a cost-effective and safe method for clinical trial monitoring.

Chapter 25: Pharmacovigilance and Regulatory Affairs

Through this unit, you will gain insight into the process and rationale behind pharmacovigilance (PV) and its central role in the clinical trials process. The chapter reviews the statistics on AEs, distinguishes between Type A and Type B AEs, and profiles seriousness of ADRs or Adverse Drug Reactions as well as the iGuard Drug Risk Rating System. Importantly, the unit covers ADR causality assessment in detail, including both severity and probability assessment. An important element of PV addressed in this module is the Individual Case Safety Report (ICSR), its structure, content and role in trial monitoring. Other concepts discussed include types of PV inspections (routine vs. ‘for cause’), PSURs or Periodic Safety Update Reports and study criteria for instituting DSMBs (Data Safety Management Boards). Finally, the module also reviews the domain of Regulatory Affairs (RA) as a function of PV, outlining roles and responsibilities of RA personnel as well as the importance of RA in streamlining the process of drug development by ensuring compliance throughout manufacturing, clinical trials, marketing and advertising.

Chapter 26: Investigational Product

In this chapter, an in-depth review is provided of the protocol for receiving, storing and dispensing the IP or investigational product. At every stage, guidelines lay down strategies for ensuring verifiability, accountability and safety of both study subjects and staff. Thus, IP handling precautions include the need for logging date of manufacture, temperature throughout transit, as well as batch number and individual unit numbers (such as bottle or tube identifiers) carefully and accurately, as well as recording shipping details and filing shipping receipts. Additionally, the unit addresses the need for IP dispensing precautions, such as limiting dispensation to authorized personnel only, as well as maintaining individual subject IP logs.

Chapter 27: Local and Central Labs

The module profiles the evolution of lab testing in clinical trials, from error-prone localized laboratory testing to centralized testing that allows homogeneity of testing procedures and measurements, thus minimizing errors and improving outcomes. The chapter reviews standards for clinical trial laboratories as per the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments), as well as providing guidelines for lab audits, including fire safety, protective gear, staff training and so forth.

Chapter 28: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of trial documentation (SDV, CRF, ICSR), quality control, pharmacovigilance, as well as IP and lab guidelines.

Chapter 29: Regulatory Documents in Clinical Trials

The chapter reviews essential documentation to be created and maintained throughout the course of the clinical trials, including the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312, besides ethics approval documents such as the IRB-approved protocol, informed consent form, subject education and study advertising materials. You will acquire in-depth familiarity with each of these forms, and learn the importance of maintaining and updating records, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. In addition, the unit summarizes the need for filing documents outlining study- and site-specific procedures, including SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

Chapter 30: CFR Title 21 Part 11 – Electronic Signatures

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR), including Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56) and so on, Series on food (100), pharmaceuticals (200 and 300) and so on, as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES), laying down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

Chapter 31: New Drug Application

Through this module, you will gain knowledge of the FDA process for evaluating a drug under development, and the role of a CRA in streamlining this process. An important distinction covered here is the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The chapter discusses in-depth the criteria used in evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, the unit covers FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators. 

Chapter 32: Trial Master File

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF. 

Chapter 33: Disclosures and Payments for PI, Site, Patients

In this chapter, FDA guidelines regulating financial disclosure are discussed in-depth, covering the definition of ‘conflict of interest’ and the stipulations of Title 21 Section 54 on disclosure requirements. The unit helpfully contrasts FDA requirements with Canadian and UK/EU policies. You will study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on ‘fair market value’ as well as the Federal ‘Anti-Kickback Statute’. The unit contains guidelines on clinical trial budgeting and subject payments. Finally, the chapter reviews IRB guidelines on advertising to recruit human participants for clinical trials, including stipulations against misleading and coercive language, as well as excessive incentives.

Chapter 34: Patient Recruitment, Retention and Compliance

The unit provides an overview of the process of patient (subject) recruitment in clinical trials, from population research to identify motives for participation, to media support for building up public awareness and interest, to community and physician outreach for referrals and enrollment. Additionally, the chapter identifies common barriers to meeting recruitment goals and outlines strategies for maximizing recruitment, such as relaxing overly stringent criteria, offering reasonable incentives such as travel reimbursement and highlighting benefits of participation. Similarly, the unit covers common causes of patient drop-out as well as strategies for minimizing drop-outs, such as improving patient experience (increased attention and listening to patients, flexible scheduling of visits to suit patients’ convenience and so on). Finally, the unit discusses novel strategies to increase patient retention and improve compliance in clinical trials; these techniques harness technology to yield better outcomes, for example, simplifying form completion through digitized forms with auto-fill features, gamifying elements of compliance reporting, and so forth.

Chapter 35: Misconduct and Fraud

This module discusses the various motives for committing scientific fraud and the fallout of fraudulent practices in clinical trials. A scale for classifying errors in clinical trial data is presented, with ‘honest, isolated mistake’ at one end of the spectrum and ‘deliberate data falsification with malicious intent’ at the other. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will gain familiarity with the signs to watch out for during the actual clinical trials process. 

Chapter 36: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, including questions on all aspects of regulatory documents, site documents (TMF and contents), trial budgeting and payments, patient recruitment and scientific fraud.

Chapter 37: Site Visit Templates 

This module contains a set of templates that you can use for documenting the details of site monitoring as a CRA, either in their current form, or in a form adapted to the needs of your own study. The templates included in this unit include:

Site Qualification Visit (SQV) – checklist for preparations, questionnaire for assessing the site prior to the actual visit, assessment form and follow-up letter

Site Initiation Visit (SIV) – agenda for visit, confirmation letter to request PI attendance during SIV, report following SIV

Routine Monitoring Visit (RMV) – confirmation letter to request PI attendance, report following RMV, follow-up letter

Site Close-Out Visit (SCOV)  – confirmation letter to request PI attendance, agenda for SCOV, report following SCOV, follow-up letter

CRA transition letter  – document notifying site PI of appointment of new monitor (yourself as CRA) 

Chapter 38: Interviewing and Career

In this unit, you will find suggestions and recommendations for making a positive impact in interviews for CRA positions, as well as tips and strategies for making rapid progress in a clinical research career.

Chapter 39: Final Examination

This module comprises a comprehensive 51-item, self-paced quiz to assess your competency in the skills and knowledge required for a Clinical Research Associate position. 

https://www.beroeinc.com/category-intelligence/clinical-research-organizations-market/

https://www.linkedin.com/jobs/search?keywords=Clinical%20Research%20Associate&location=United%20States&geoId=103644278&trk=public_jobs_jobs-search-bar_search-submit&position=1&pageNum=0

https://www.centerwatch.com/articles/24791-demand-for-experienced-clinical-trial-professionals-outpacing-supply-acrp-says

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/

https://www.niaid.nih.gov/research/dmid-investigational-product

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860

https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6%28R1%29.pdf

https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol/

https://iaocr.com/finding-first-clinical-research-job/

https://jobs.newscientist.com/en-au/article/a-career-in-clinical-research/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/

St. Germain DC, Good MJ. 2017. Data management in clinical trials. In: Gallin JI, Ognibene FP, Lee Johnson L, editors. Principles and practice of clinical research. San Diego: Academic Press. p. 531-545. ISBN 978-0-12-849905-4

https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/04/clinical-study-monitoring-competencies.pdf

https://www.clinicalleader.com/doc/starting-a-career-in-clinical-research-things-we-wish-we-knew-0001

https://www.proclinical.com/blogs/2021-9/how-to-get-a-job-as-a-clinical-research-associate-cra

https://acrpnet.org/2018/06/11/5-clinical-research-trends-emerge-at-acrp-2018/

https://www.collegechoice.net/sciences/clinical-research/best-masters-degrees/

https://acrpnet.org/certifications/cra-certification/

https://www.socra.org/certification/program-overview/

Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training

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How to become a clinical research associate (CRA)

Clinical research is an important step in developing and evaluating new medical products. For people with qualifications or experience within life sciences , a career in clinical research can offer many rewarding, interesting and varied opportunities and career paths . With the demand for new prevention methods and treatments ever increasing, clinical research associates are needed by pharma, biotech, medical device companies and CROs around the world. Here are some things to consider if you’re looking to kick-start a career in clinical research and how to become a clinical research associate:

What is a clinical research associate?

'A clinical research associate (CRA) is someone who monitors the running of clinical trials. A CRA may be involved in some or all stages of the clinical trials process depending on the type of position or the employer.

What are the responsibilities of a clinical research associate?

Typically, the key responsibilities of a CRA will include monitoring study sites and clinical activities, updating study documentation, maintaining clinical data systems and coordinating research procedures.

If you are a field-based CRA, you will spend most of your time travelling to different locations, dealing with medical professionals in trial centres, healthcare practices, or hospitals. The remainder of your time may be spent either office-based or working from home, but this will depend on the company. Some companies will have in-house CRA roles who just focus on document review and management and will make site visits only occasionally.

What is the demand for clinical research associates?

Driven by a rise in the number of healthcare facilities, increasing healthcare expenditure, technological and research capabilities, and an aging population, the need for new treatments has increased exponentially in recent times. This has led to a rise in the number of companies hiring for new clinical research jobs and this is likely to keep gaining momentum in the years to come.

What qualifications or training do I need to get a clinical research associate job?

A degree in a life science or other health-related discipline is usually needed to start a career in clinical research. However, there are courses and training available that can help you get a foot in the door if you haven’t got the desired qualifications.

Qualifications:

Although not usually necessary, a Master's degree (MSc. or equivalent) or a PhD can be advantageous and could give you valuable experience in clinical research. A relevant PhD can also be beneficial, as some companies will see this as relevant work experience and count it towards reaching promotions to more senior positions.

Certifications:

The Association of Clinical Research Professionals (ACRP) offers a certification exam to become a Certified CRA. Even though, for most CRA roles, this is not a requirement, being CCRA certified is a real advantage. The exam covers everything a CRA will need to know from scientific concepts and research design to product development and regulation, to data management.

There are lots of courses out there that can provide you with a detailed understanding of what it takes to a be CRA. Before you sign up to anything, make sure it is a recognised training course that is recommended by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

How do I get the right experience for a clinical research associate job?

Getting your first job in clinical research can be challenging, and many graduates at the start of their clinical research career can become frustrated by the 'catch 22' scenario: they can't find work because of a lack of experience and they can't get experience because they can't find work.

Without relevant work experience, you will be more likely to secure a job as a clinical trials assistant (CTA). A CTA role will help support all processes of the trial and give you the required experience to move into a clinical research assistant role.

Generally, larger companies are far better equipped to take-on inexperienced graduates and are more likely to offer programmes such as graduate assessment days and internships. Research who the top pharmaceutical companies , medical device manufacturers and contract research organisations are, and look out for opportunities on their career websites. Their social media pages are also great places to find out about graduate programmes, so keep a close eye on them too.

You might be able to gain experience by working on academic projects or working within a healthcare body. Although these are good ways to gain experience, moving into a commercial environment later can be quite different and you might have to take a more junior position with a lower salary than you are used to.

Tips for applying to clinical research jobs            

Even with all the relevant qualifications, skills and experience that you need to become a clinical research associate, there can still be challenges in landing your perfect clinical research job . A few simple changes to your approach can give your CV a better chance of success .

Be realistic

Be realistic about the types of jobs that you can attain. If you don’t have industry experience, you are unlikely to be hired for anything above an entry level role. Don't apply to senior CRA jobs or clinical project manager roles unless you have been working as a CRA for some time already and have the required experience. Save yourself the time and effort in making lots of speculative applications and take a more targeted approach.

Highlight your relevant experience

If you are applying for a clinical research associate job , ensure that you read each job description carefully and highlight on your CV the relevant experience that matches the specific description. Your cover letter should be personalised to the specific company and describe why you want to work for that company and which of your skills match the specific requirements of the role. Employers and life sciences recruitment consultants are looking for the most relevant applications and will readily discard those that have put little effort into personalising it.

Make sure you network

Remember, not every company will advertise all its vacancies so you should consider other approaches too. Networking with recruiters and hiring managers and uploading your CV to a database are two great ways that employers and recruiters with CRA jobs can find you.

What are the different career paths you can take?

There are a variety of ways to progress your career in clinical research , with pharma, biotech, and medical device companies and CROs all offering opportunities. Roles will vary from company to company but typically CRAs will progress to be a senior clinical research associate. With the right experience, CRAs will have the potential to progress all the way to clinical director or even VP level.

Once a CRA has reached senior level, there are typically three main routes a career in clinical research can take. You will either be a manager of the trial process, a manager of people or a project manager.

Clinical trial management:

Usually responsible for managing, coordinating, and overseeing various aspects of the trial. Typical duties will involve supervising staff, implementing study tools and documents, overseeing trial budgets and providing strategic input into trials.

Clinical team management:

Responsible for acting as the direct line manager to associates. Clinical team managers will manage and support team members, ensure staff are trained effectively, review the effectiveness of business processes and plan professional development activities.

Clinical project management:

Involved with the planning and directing of clinical trials and is also responsible for evaluating clinical data. Day-to-day tasks include, maintaining study records, ensuring activities are being delivered on time and on budget, interpreting study data and developing trial plans.

Are you already a CRA professional or looking to start your career in clinical research? We might have something that is the right fit for you. We are looking for experienced professionals for a broad and extensive range of clinical research positions. Take a look at our latest clinical research jobs and apply today.

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Average Clinical Research Associate (CRA) Salary

The average salary for a Clinical Research Associate (CRA) is $74,947 in 2024

Featured Content

What is the pay by experience level for clinical research associate (cra)s .

An entry-level Clinical Research Associate (CRA) with less than 1 year experience can expect to earn an average total compensation (includes tips, bonus, and overtime pay) of $62,775 based on 240 salaries. An early career Clinical Research Associate (CRA) with 1-4 years of experience earns an average total compensation of …Read more

What Do Clinical Research Associate (CRA)s Do?

Clinical research associates (CRA) are responsible for assisting in the clinical research process, providing advanced technical expertise in steps such as handling supplies, ordering tests, and collecting results, presenting specific research information to the public, and a variety of administrative tasks. CRAs must follow strict privacy and safety regulations to prevent problems with subjects and ethical concerns; they must also be organized and pay close attention to detail when conducting …Read more

How do Clinical Research Associate (CRA)s Rate Their Jobs?

Common health benefits for a clinical research associate (cra), gender breakdown for clinical research associate (cra)s.

FAQs About Clinical Research Associate (CRA)s

What is the highest pay for clinical research associate (cra)s.

Our data indicates that the highest pay for a Clinical Research Associate (CRA) is $105k / year

What is the lowest pay for Clinical Research Associate (CRA)s?

Our data indicates that the lowest pay for a Clinical Research Associate (CRA) is $50k / year

How can Clinical Research Associate (CRA)s increase their salary?

Increasing your pay as a Clinical Research Associate (CRA) is possible in different ways. Change of employer: Consider a career move to a new employer that is willing to pay higher for your skills. Level of Education: Gaining advanced degrees may allow this role to increase their income potential and qualify for promotions. Managing Experience: If you are a Clinical Research Associate (CRA) that oversees more junior Clinical Research Associate (CRA)s, this experience can increase the likelihood to earn more.

CCRA Certification

Ccra® (certified clinical research associate) is a credential formally recognizing clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor., this trusted mark of excellence in clinical research is awarded to clinical researchers who have demonstrated proficiency of specific knowledge and skills by passing the standardized ccra® certification exam., read the latest acrp ccra® blog, “spotlight on the clinical research associate career pathway and resources” >.

Apply for Your Exam

Clinical research professional with 3,000 hours of verifiable work experience are eligible to sit for the CCRA ® Exam. Complete eligibility criteria is defined in the Academy’s  policy manual .

What qualifies as work experience, work related to human subject research, paid contractual agreement – employer/employee, can be verified by acrp through employer, what is excluded from work experience, any work that is part of a degree track or education program, any experience older than ten years, internships paid or unpaid.

ACRP may grant one experience waiver amounting to 1,500 hours of work experience to applicants who meet one of the following criteria:

Hold an active acrp certification, have successfully completed a clinical research education program*, what qualifies as a clinical research education program*, must be aligned with the topics found in the corresponding detailed content outline (dco), must have a valid third-party accreditation, must provide applicants with knowledge that is equivalent to 1,500 hours of knowledge earned through employment, *program approval is at the discretion of acrp and will not be reviewed or pre-approved outside of a paid application..

The CCRA ® exam consists of 125 multiple choice questions that must be answered within 180 minutes.

The exam is referenced only to the international conference on harmonization (ich) guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)., the following are the only references for which the ccra ® certification exam content can be supported:, ccra ® exam detailed content outline >, guideline for good clinical practice e6 (r2) >, definitions and standards for expedited reporting (e2a) >, general considerations for clinical trials (e8) >, statistical principles for clinical trials (e9) >, clinical trials in pediatric population (e11) >, the declaration of helsinki (doh) >, the global ccra ®  exam committee uses psychometrically sound practices to develop certified clinical research associate (ccra) examinations that meet the current test specifications as determined by the most recent job task analysis (jta)..

Review the Detailed Content Outline and make sure your experience and work hours are appropriate, as outlined in the Eligibility tab.

We also strongly encourage you to review the entire acrp certification handbook , which provides full details about every facet of acrp certification..

Create a free ACRP account so you can begin the application process. Follow the on-screen prompts to enter any requested information and documentation.

If you already have an acrp account, please proceed to step three., create account >.

You’re almost there! Please note, applications selected for audit will undergo a formal review by ACRP’s subject matter experts. In most instances, you will receive a status update about your application within 7 business days.

In accordance with the americans with disabilities act, acrp will provide reasonable accommodations for candidates with disabilities. please complete this special accommodations form for submission with your application before proceeding., acrp’s testing partner psi offers in-person testing, as well as on-demand remote testing available 24 hours a day, every day, during the testing windows., watch these videos to learn what to expect from each option before scheduling your exam..

Find Test Centers Near You >

Schedule your in-person exam >.

Schedule Your Remote Exam >

Check system requirements >.

The best way to prepare for the CCRA ® exam is to fully understand the scope of the exam content and its references.

Please be sure to thoroughly review the following:, acrp certification handbook >, remember: the exam is referenced only to the international conference on harmonization guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)..

We also recommend leaning on your community! Thousands of ACRP Certified members have been in your shoes. They are active community members and always willing to share tips and advice for ACRP exam prep.

Visit the acrp community >.

ACRP offers a variety of training and continuing education programs focused on the key ICH guidelines covered in the CCRA ® exam.

Learn more >.

Exam results are shared immediately at the conclusion of your exam, but PSI will send you an email with your full score report within 24 hours.

Your acrp account will reflect your results within 24 hours..

Congratulations! You just passed a major milestone on your professional journey and are now a member of the elite club of ACRP Certified clinical research professionals.

Keep an eye on your email because you will soon receive information from our digital badging partner credly about claiming your digital badge and how you can use it to tout your accomplishment. also learn how to use your new credential by reviewing the  certification mark policy ., you have 2 years to keep your certification in good standing by continuing your professional development, and we’ll be right there with you every step of the way. in the meantime, we highly recommend you review all the details about maintenance of certification . don’t leave it to the last minute.

Don’t worry. It happens to the best of us. Give it another try!

Refer to your acrp certification examination results email or the acrp certification handbook for guidance on the next steps in your certification journey., upcoming testing dates, spring 2024 testing february 15 – may 15, 2024, fall 2024 testing july 15 – october 15, 2024, 2024  registration dates and fees, early bird registration acrp members – $435 nonmembers – $485 spring 2024:  october 15 – december 31, 2023 fall 2024:  may 15 – july 15, regular registration acrp members – $460 nonmembers – $600 spring 2024:  january 1 – april 30 fall 2024:  july 16 – september 30, join acrp & save, joining acrp helps you save money. more importantly, acrp is where you will find the very best of what you need to design a career path that’s uniquely your own. connections through an engaged community. growth through gold-standard training. and elevation through rigorous certification., explore membership >, exam preparation, congratulations on your decision to earn the most recognized and respected endorsement of clinical research competency — acrp certification. as you start this important journey in your career, we’re here to support you every step of the way..

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Clinical Research Associate

Clinical Research Associates (CRA) have a vital role in our clinical trials. We own site and patient results. We understand the site and patient ecosystem and our role as site manager.

We perform monitoring and site management activities for Phase I-IV clinical research projects. Our job is to assess the progress of clinical projects at assigned sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Syneos Health and Sponsor standard operating procedures and all applicable local and federal regulatory requirements.

Our CRAs are passionate to change lives, and they do every day here at Syneos Health.

Monika Sr Clinical Research Associate I

As a CRA at Syneos Health, I feel like all of my ideas are heard and appreciated. The company listens and works together to make itself better. I am supported in every possible way of my career.

Hear why Darby has stayed at Syneos Health.

• Functional Service Provider (FSP)    
• Full Service    

Functional Service Provider (FSP)

An FSP relationship is a partnership between Syneos Health and a Sponsor. Every partnership is unique with each one tailored to achieve our customer’s visions and goals. This allows us to grow and evolve with our customers as their portfolio needs evolve.

For Syneos Health it means that colleagues who like structure and predictability, and who truly enjoy relationship building in the work environment, tend to thrive in FSP environments.

Sponsors look to Syneos Health for technical expertise. They expect our colleagues to be an extension of their team and to bring new ideas; demonstrate expertise in technology and processes; escalate recommendations for improvements and take opportunities to innovate. In other words, Syneos Health has a voice.

Full Service

Full Service is a prominent service model among CROs and critical to Syneos Health.

The Full Service environment is dynamic with multiple Sponsors and project assignments. Our Syneos Health colleagues gain broad exposure to therapeutic areas and multiple Sponsors’ processes, roles, technology, financial experience, end-to-end project work and business development opportunities.

Timelines can be fast paced and colleagues in a Full-Service model tend to thrive on variety and are not averse to change, truncated timelines and a degree of unpredictability.

Date Posted

Clinical data reviewer, project manager ii. spain. sponsor dedicated, cra ii - sr cra ii, (fsp) taiwan, clinical research associate ii (fsp sponsor dedicated, hong kong), cra ii or sr cra (fsp sponsor dedicated, malaysia), cra ii/ sr cra- central region, ssu & regulatory specialist - hybrid in lucerne, fsp, sponsor dedicated, cra ii / cra iii/ sr cra, cra (all levels), oncology, north/east germany, sponsor-dedicated, cra in oncology - home based in clermont ferrand - sponsor dedicated, cra i - sr cra ii, south korea, inside syneos health.

Discover Your Future with Syneos Health

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Syneos Health® is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.

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CLINICAL RESEARCH ASSOCIATE, LEAD, DCRI

Durham, NC, US, 27710

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

MegaTrials CRA Lead (Job Code 2985)

Position Summary

Manage the development, coordination and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects with guidance, including trial-specific processes and systems, and daily supervision of the Mega Trial team responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOPs, applicable international, federal and state regulations, and ICH guidelines.

** NOTE: This position may have an opportunity to work remotely.  All Duke University and Duke Health remote workers must reside in one of the following states or districts:  Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio and New Hampshire

Core Job Responsibilities

• Provide leadership for the Mega Trial project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work:
• Define, assign, coordinate, oversee and assess utilization and productivity of team members’ daily in-house activities according to trial-specific scope of work, budget, and timelines.

Define, assign, coordinate, oversee and assess utilization and productivity of sub-contractors including independent contract CRAs, vendor or sponsor-provided CRAs, and other contracted services.

• Provide site management and clinical monitoring expertise, and leadership to assigned team. Provide advice and guidance to team members for assessment, resolution, and documentation of site and project issues.
• Identify resource needs and supervise team members’ work assignments, utilization and productivity.
• Direct and prioritize team efforts and assess overall team progress against project timelines and metrics. Develop performance standards for project team. Identify and notify project leader of emerging out of scope activities and study guidelines. Evaluate impact on resource needs, study processes and related documents.
• Review and approve team deliverables focusing on quality and timeliness of all activities within the defined scope of work.
• Oversight, and management of the Mega Trials SONAR report for each trial including ARO SONAR report when applicable.
• Coordinate the development, use and maintenance of study-specific processes, related documents, templates and other site management, communication, monitoring and regulatory tools.
• Define site selection and activation guidelines and related activities with the project leader, the principal investigator, and the sponsor. Approve sites in collaboration with the project leader and the sponsor.
• Train and supervise the team on trial-specific collection, review and approval of clinical trial documents and associated processes. Provide final approval of essential clinical trial documents.
• Observe for consistency in the conduct of the study and data collection according to the protocol and study objectives. Oversee identification of study and site issues and assist with resolution and documentation.
• Provide management of the development, implementation and maintenance of the clinical trial management system, related tracking tools and status reports.
• Apply best practices to site management clinical trials processes.
• Serve as key site management trial-team member to internal and external partners and to the project core team (project leader, principal investigator and other functional group key representatives).
• Collaborate with internal and external partners to develop trial-specific tools and processes, with guidance, for efficient management of tracking site and study status, enrollment, data collection, query resolution, and other trial activities.
• Provide input regarding the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports.
• Facilitate communication between designated internal and external contacts (including contracts, clinical supplies, pharmacy, and sponsor) and study sites. Facilitate cross-functional team communication and proactive problem solving regarding study progress and trial issues with guidance.
• Manage production, review and approval of trial-related reports, including site status reports, site payments, regulatory status reports, trip reports, and expense reports for internal and external dissemination. Review reports for identification and resolution of study and site issues. Notify appropriate team members of findings and action plan.
• Organize, lead, and participate in study teleconferences and meetings with the trial team and other study partners
• Coordinate and oversee trial-specific training for project team members which may include therapeutic in-service, reference materials, investigator meeting, and team training, Provide and document regular feedback to individual team members. Maintain documentation, providing specific examples of performance issues.
• Recognize accomplishments of individual team members and the team as a whole.
• Manage all aspects of performance management including compiling and providing feedback to the team members’ annual performance evaluations, identifying strengths and areas for improvement using specific examples, and providing input for Individual Development Plans. Assist with development and delivery of performance reviews and work improvement plans.
• information exchange
• Attend appropriate Mega Trial leadership meetings, department meetings and organizational meetings. Encourage team members to attend appropriate team, department and educational meetings.
• Assist in the development, implementation and revision of processes, SOPs and standard forms.
• Oversee team dynamics to foster professional relationships.
• Maintain awareness of developments in clinical research regulations and therapeutic areas by reading related literature, attendance at professional meetings and research seminars.
• Encourage and support cross-functional and therapeutic information exchange.
• Participate in special assignments as requested by project leader.
• Interview job candidates and make hire recommendations for teams.
• Complete administrative activities accurately and in a timely manner, e.g., time tracking, attendance reports, training file.
• Encourage team to seek opportunities for personal development.
• Receive and review audit findings, develop action plan for audit response and provide input for formal audit response with guidance.
• Perform other related duties incidental to the work described herein

Education/Training

Bachelor’s degree preferable in clinical, health or life science.

Four years directly related experience in clinical trials research or 5 years four years directly related experience in clinical trials research.  Prefer 3 years directly related CRA or clinical trial management experience.

OR    AN    EQUIVALENT    COMBINATION    OF         RELEVANT                  EDUCATION         AND/OR EXPERIENCE

Required Knowledge, Skills and Abilities

A sterisk (*) or other notation to distinguish KSAs that are required at the time from those that are expected to be demonstrated at the conclusion of orientation, training, or probationary period for the position.

• * Strong technical spelling and grammar skills, including reviewing and proof reading of business documents and communications
• * Ability to write, speak, and present strategies clearly and concisely in a variety of communication settings and styles
• * Strong interpersonal skills, ability to establish and promote positive business relationships, customer service oriented
• Ability to collaborate with team members to achieve trial-specific goals within specified timelines
• Ability to collaborate with internal and external partners to achieve departmental and organizational goals
• Ability to lead others and foster teamwork; ability to manage, motivate and lead teams
• * Proficient computer skills including MS Office, Word, Excel and PowerPoint; able to learn and use computer applications
• Ability to train and coach site management and clinical monitoring team members
• Ability to direct and manage competing individual and team activities to meet trial objectives, timelines and budget
• * Ability to use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions
• * Strong knowledge of medical terminology
• Understanding of scientific application to clinical trials research
• * Technical knowledge and skills for monitoring procedures and practices
• Knowledge of clinical research trial operations
• * Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials
• Understanding of departmental SOPs and systems
• *Ability to travel 25%, some for consecutive nights

Registration, Certification or Licensure

• Valid U.S. driver’s license
• ACRP CCRC or CCRA, or SoCRA CCRP is a plus

Working Conditions

• Extensive use of telephone and electronic mail systems
• Extensive repetitive keyboarding motions
• Extensive focusing on computer monitor for long periods of time
• Occasional lifting and moving of heavy business documents
• Occasional travel with a laptop computer and heavy business documents

Bachelor’s degree pre ferable in clinical, health or life science.

Four years directly related experience in clinical trials research or 5 years four years directly related experie nce in clinical trials research.  Prefer 3 yea rs directly related CRA or clinical trial management experience.

OR    AN    EQUIVALENT    COMBINATION    OF    RELEVANT          EDUCATION                AND/OR EXPER IENCE

·     * Strong technical spelling and grammar skills, including revi ewing and proof reading of business documents and communications

·     * Ability to write,< span>speak, and present s trategies clearly and concisely in a variety of commu nication settings and styles

·     * Strong interpersonal skills, abili ty to establish and promote positive business relationships , customer service oriented

·     Ability to collaborate with team memb ers to achieve trial-specific goals within specified timeli nes

Minimum Qualifications

Work requires graduation from an accredited degree program providing 1. Completion of an allied health degree (e.g., Respiratory Therapy, clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus four years of healthcare experience; or one of the following equivalents: Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or 2.Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or 3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or 4. Completion of a bachelor's degree plus a minimum of five years closely related research experience. **State of North Carolina license may be required.**

None required beyond that described above OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Nearest Major Market: Durham Nearest Secondary Market: Raleigh

Duke is an Affirmative Action / Equal Opportunity Employer committed to providing employment opportunity without regard to an individual’s age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Read more about Duke’s commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.