clinical research associate in usa

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Found 16 jobs

Senior director for clinical study.

• Globally competitive, can offer additional support based on individual qualifications and needs.
• SINOVAC LIFE SCIENCES CO., LTD.

Qualification and Requirements MD or PhD on oncology/immunology/another relevant field. 5+ years clinical experience in cancer treatment, especia...

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Nanyang Assistant Professorship (NAP)

• Singapore (SG)
• Commensurate with education and experience
• Nanyang Technological University

NTU invites outstanding early-career researchers (postdoctoral fellow or equivalent) to apply for an appointment as a Nanyang Assistant Professor.

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Faculty Biostatistics & Epidemiology - Quantitative Health Sciences, Cleveland Clinic

• Cleveland, Ohio
• Commensurate with experience
• Cleveland Clinic/Dept. of Quantitative Health Sciences

Faculty to lead biostatistical collaborations with the Musculoskeletal Research Center, Cleveland Clinic Orthopaedic Institute.

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Senior Director, Clinical Research (MD required)

• Collegeville, Pennsylvania, United States;
• Competitive

Job Description ROLE SUMMARY The purpose of the Senior Director of Clinical Research role is to coordinate and lead the development of first in m...

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Associate Director (AD) in the Radiation Research Program (RRP)

• Rockville, Maryland
• National Cancer Institute (NCI)

The National Cancer Institute (NCI) is recruiting for an Associate Director (AD) in the Radiation Research Program (RRP).

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Associate Director of Corporate and Foundation Relations

• North Grafton, Massachusetts
• Tufts University

The Tufts Office of Corporate and Foundation Relations seeks a dynamic Associate Director to propel the Dean’s vision for growth...

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Senior Director, Vaccine Clinical Research & Development (MD required)

The clinician medical monitor should be able to function independently and have direct experience with all the steps in designing and delivering re...

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Director, Clinical Research (MD required)

The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a singl...

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Research Associate

• Roanoke, Virginia
• Commensurate with Experience
• Virginia Tech

The Sassi Lab at the Fralin Biomedical Research Institute is seeking a full time Research Associate to assist in general laboratory operations and ...

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The 2025-2026 University of Pennsylvania and CHOP Postdoctoral Fellowships for Academic Diversity

• Philadelphia
• See job description.
• University of Pennsylvania

The 2025-2026 University of Pennsylvania and CHOP Postdoctoral Fellowships for Academic Diversity Location: Philadelphia, PA Open Date: Aug

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Open Rank Faculty Position in Head and Neck Surgery Research

• Rochester, Minnesota (US)

The Department of Otolaryngology – Head and Neck Surgery at Mayo Clinic is seeking an exceptional principal investigator in the field of Head and N...

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Chief Scientific Administrator - Academic Rank DOQ

• Omaha, Nebraska
• DOQ - Depends on Qualifications
• UNMC Department of Neurological Sciences

Hiring Chief Scientific Administrator for the Department of Neurological Sciences (DONS) and Great Plains IDeA-CTR.

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Assistant Professor or Higher

• El Paso, Texas
• Compensation is commensurate upon the qualifications
• Texas Tech University Health Sciences Center El Paso -Department of Molecular and Translational Medicine

Assistant Professor or Higher Department of Molecular and Translational Medicine Center of Emphasis in Infectious Diseases  The Department of Molec...

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Post Doctoral Fellow - Indiana University School of Medicine (IUSM) - Department of Ophthalmology

• Indianapolis, Indiana
• Salary will be commensurate with experience and will adhere to current IUSM guidelines
• Indiana University School of Medicine - Department of Ophthalmology

Our research focus is retinal cell biology with the goal of discovering small molecule therapy for photoreceptor degenerative disorders.

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Assistant Professor- Developmental Therapeutics

• Texas Tech University Health Sciences Center, SOM, Cancer Center, Lubbock, TX
• Rank and salary are dependent upon qualifications and experience.
• TTUHSC Cancer Research Center

Asst Professor level tenure-track position in pediatric cancer developmental therapeutics. Preference given to pediatric oncology physician-scientists

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Vice President- Vaccine Clinical Research & Development

• Collegeville, Pennsylvania, United States;United Kingdom - MarlowCambridge, Massachusetts, United States;

The primary purpose of the job is to oversee and ensure that vaccine clinical research and development program(s) are planned and implemented to me...

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Faculty Positions – Assistant, Associate and Full Professor

• Miami, Florida
• The University of Miami offers competitive salaries and a comprehensive benefits package.
• Miami Miller School of Medicine - Desai Sethi Urology and Sylvester Comprehensive Cancer Center

Seeking outstanding scientists for faculty positions at the assistant through full professor levels with experience in genitourinary cancers.

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Postdoctoral Fellow, Cancer Prevention Fellowship

• See complete application for details
• the National Cancer Institute (NCI)

The National Cancer Institute (NCI) Cancer Prevention Fellowship Program (CPFP) is now accepting applications for Cancer Prevention Fellows

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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.

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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.

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I'm working toward a better future for patients. And I do it

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We are celebrating Hispanic Heritage month. Learn more about how Parexel engages employees from diverse backgrounds.

The heart of all we do

Trialing new treatments. Advancing healthcare. Reinventing medicine as we know it. When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish.

Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart ™.

Parexel's 360° Patient-First Portfolio ensures that the patient is represented at every step

22,000+ employees worldwide

40+ years putting our heart into all we do

1,167 clinical projects in 16 therapeutic areas and 271 indications in 2022

Work that puts patients first

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Featured Career Areas

Biostatictician.

Develop your statistical skills, gain exposure to multiple therapeutic areas, and become involved in business development activities. As a Biostatistician at Paraxel, you are one of the first indivduals to see if a new treatment is effective.

Clinical Research Associate

As a CRA you will use your expertise to build and maintain the site relationship and ensure they’re set up for success. Our CRAs take their work seriously, demonstrate empathy, and act with heart because everything we do has the potential to impact patient lives.

Data Manager

In partnership with client teams, you’ll work to understand the challenges and opportunities within patient data. You’ll help transform how we acquire, manage, and assemble data to optimize study design.

Project Leader

Your leadership has a direct impact on the projects, teams, and clients you work with. In this role, you’ll be empowered to deliver projects to the benefit of the patients we serve.

Regulatory Consultant

Be a strategic guide in getting products to market faster, and smarter. Your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

Statistical Programmer

From initial planning meetings at the study design stage through to implementation and execution, our team of skilled statistical programmers employs industry-accepted statistical tools and techniques, as well as innovative consulting, to provide the quality and efficiency of projects.

Why Parexel

Flexibility, Recognition, and Support

Benefits vary by country, but Parexel is passionate about our team’s overall wellness. Our Flexible Work Program offers the choice to work from where you want and how to accommodate personal responsibilities and interests outside of work. Our Recognition Program allows colleagues and managers to acknowledge teamwork, helping each other, and helping change the lives of patients. It is our priority to put people first so we can fulfill our mission and accomplish our best work.

Getting the most out of learning

We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career. In order to ensure the highest quality of work for our clients and our patients’ safety, Parexel takes a targeted and balanced approach to support both the immediate training needs and the long-term development investment in our employees.

Focused Business Areas

Functional Service Provider

Within our outsourcing model, you are deployed as an experienced colleague for our customers, benefiting from exposure to both the clinical research organization (CRO) and sponsor experience.

You are a trusted partner to Biotech clients – on the forefront of new science. Agile and solutions-oriented, you provide guidance on how to solve challenges.

global recruitment events

2023 Scrip Awards "Best Contract Research Organization" – Full-service category

2023 SCRS’s Eagle Award for strong site relationships

Recognized by Flexjobs for our remote- and hybrid-friendly culture

LinkedIn Top Company for Career Progression in Healthcare

CRO Leadership Award for 10 consecutive years

“Silver” rating by Ecovadis for business sustainability exceeding all industry benchmarks

Top 20% ranking on the Human Rights Campaign’s Corporate Equality Index 2022

Catalyst Award Winner for advancing women in the workplace

2023 scrip awards "best contract research organization" – full-service category.

2023 SCRS’s Eagle Award for strong site relationships

“Silver” rating by Ecovadis for business sustainability exceeding all industry benchmarks

Top 20% ranking on the Human Rights Campaign’s Corporate Equality Index 2022

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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

The ultimate guide to clinical research monitoring.

Working together, we can reimagine medicine to improve and extend people’s lives.

Clinical Research Associate

About the role.

Your Key Responsibilities:

Trial Monitoring strategy:

• Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis)

Allocation, initiation and conduct of trials: • Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries • Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures • Facilitates the preparation and collection of site and country level documents • Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects and performs continuous training for amendments and new site personnel as required.

• Conducts continuous monitoring activities (onsite and/or remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety.

• Accountable for continuously updating all relevant electronic systems to perform job functions

• Takes on the responsibility as SME (Subject Matter Expert) as needed

Delivery of quality data and compliance to quality standards:

• Monitors studies as per current legislations, ICH/GCP and Novartis standards • Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring.

•  Identifies, resolves & escalates issues appropriately • Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry

• Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as well as Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to achieve key accountabilities

•Partners with SSU CRA to ensure seamless transition of site responsibility

Role Requirements:

BS/BA degree. Scientific or healthcare discipline preferred

• Prior experience in pharmaceutical clinical research required.

• 0-2 years’ experience in site monitoring preferred but not required. • Excellent knowledge of the drug development process specifically clinical trial/research • Knowledge of international standards (GCP/ICH, FDA, EMEA) • Ability to manage multiple priorities and manage time efficiently.

• Excellent Site management capabilities with demonstrated negotiating and problem-solving skills

• Strong communicator and presentation skills (oral and written)

• Fluent in both written and spoken English

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining

to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $112,800- $169,200 annually; however, w hile salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period.  Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about

suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

Accessibility & Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.