Becoming a Clinical Research Associate (CRA) - Education, Certification & Career Outlook

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 the ability to read, interpret, and understand 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 on a regular basis.

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

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, it is possible to become a certified CRA with a high school diploma and between 3,500 and 6,000 hours of qualifying work experience (depending on 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 Option 3

  • Complete 6,000 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)

  • Complete 4,500 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 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 quality 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 2

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

ACRP Option 1

  • Complete 3,000 hours performing essential job 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 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
  • GRE scores
  • 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 are 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-hour 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, and clinical research terminology.

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

Washington University in St. Louis, Missouri has a range of 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 a way that is ethical, compliant, and safe.

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 get their careers started. Anyone with any educational background can pursue University College’s 21-credit-hour undergraduate certificate in clinical research management to enhance career skills or make a resume more competitive.

Students who already have a BA or BS have options at Washington University as well. Experienced professionals in the clinical research field who wish to seek formalized training can earn a 21 credit-hour advanced certificate in clinical research management, or a 30 credit-hour 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 option.

Although the coursework in each of these programs 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.

Barnett International – Online Seminar

Designed for CRAs with two years of experience or less, this online clinical research associate on-boarding 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.

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 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, and 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) in order 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, disease spreads across borders, and in an age of increased resistance to antibiotics, new ways to fight bacteria will be needed. Furthermore, with an aging U.S. population comes increased rates of chronic conditions the subsequent reliance on pharmaceuticals to improve people’s quality of life.

It’s not surprising that the Bureau of Labor Statistics (2019) predicted a 11 percent increase in openings for medical and clinical laboratory technicians between 2018 and 2028, roughly double the average growth anticipated across all U.S. occupations during that same decade.

Lastly, while the BLS doesn’t track salaries for CRAs, PayScale.com (2020)—a site which relies on self-reported data—found that the median annual salary for a CRA was $64,162. Specialized skills in CRA that increased salaries included oncology (11 percent pay increase over average), good clinical practices (9 percent), and regulatory compliance (6 percent).

Years of experience, predictably, aslo has an impact on salary. Entry-level CRAs earn 15 percent below the average, while experienced CRAs (ten to 19 years) earn 26 percent above the average and late career CRAs (20+ years) earn 36 percent above the average.

Becca Brewer
Becca Brewer Writer

Becca Brewer is the co-founder of Limitless: An Adventure to Build a Better Future on a Thriving Earth. Limitless exists to inspire people to join the millions across our planet who are already taking small and mighty steps to heal our earth in their everyday lives. You can follow the adventure on Instagram at @LimitlessEcoAdventure and join the project at Limitless.Eco. In her life before Limitless, Becca earned a master of education in human sexuality, where she connected with other graduate students earning dual degrees in social work, counseling, and sex therapy.