What is a Clinical Research Associate?
CRAs meet with patients, practice FDA-approved methodology, conduct research and ensure that clinical trials adhere to established state and national regulations. Clinical Research Associates work in a clinical setting to implement research studies that investigate new medications or treatments. They meet with patients to discuss the guidelines of the study, measure vital signs, and record data that can be reported to the organization conducting the research study. They work alongside doctors, who are responsible for managing the patients from a healthcare perspective.
There is no specific unique required education level for CRAs, but most have at least a Bachelor's degree. Voluntary certification is available through the Association of Clinical Research Professionals or the Society of Clinical Research Associates. In order to successfully work on clinical research studies, CRAs need strong professionalism, patience, interpersonal skills, and detail orientation.
Clinical Research Associate Certification
Certification for clinical research associates is offered by the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Once candidates meet requirements and pass a written exam, applicants will be certified as CCRAs (certified clinical research associates) or CCRPs (certified clinical research professionals for SoCRA certification). Both certifications are voluntary.
ACRP's certification requirements include a combination of a degree, completion of a clinical research program and work experience calculated in hours. For example, applicants with just an associate degree would need 4,500 hours of work experience to qualify. An applicant with an associate degree and clinical research education would only need 3,000 hours of work experience.
Similarly, applicants must also meet SoCRA's educational and work experience requirements prior to taking its examination. Applicants who do not have formal training in clinical research would need two years of experience in the last five years to qualify. Applicants with formal education need less work experience.
As of February 2021, the Association of Clinical Research Professionals now offers an option to take your CCRA certification exam online from home. This will be a great option for people who are interested in earning their CRA certification online.
Clinical Research Certification Courses
There are a variety of different degree programs that you can pursue if you're interested in studying clinical research and preparing for a CRA certification exam. The best choice for you will vary based on your educational experience and the amount of time you would like to spend studying.
Clinical Research Associate's Degree
One option is an Associate's Degree in clinical research, which is a two-year program. While studying for your Clinical Research Associate Degree, you will take classes in important topics like statistics, biology, and research design. This is a good option for people who are looking to get into the workforce as quickly as possible. Clinical research associate courses include:
- Biology
- Statistics
- Research Ethics
Clinical Research Bachelor's Degree
If you're interested in a longer course of study, a Bachelor's degree in clinical research will allow you to spend more time gaining an in-depth understanding of clinical research concepts. This is an excellent choice for people who want to go on and gain advanced degrees, like Master's degrees in clinical research. Some classes you'll take for this degree include:
- Biology
- Physiology
- Statistics
- Research design
- Research ethics
Master's Degree in Clinical Research
If you already have a Bachelor's degree, a Master's Degree in clinical research would also be a valuable option to prepare you for CRA certification. This program will take 1-2 years to complete, and you'll take courses on topics like:
- Pharmacology
- Advanced research design
- Bioethics
- Biostatistics
Certificate Programs in Clinical Research
Finally, there are numerous Clinical Research Associate certification programs that can be taken online or in person to earn certification as a Clinical Research Associate. These programs can be completed during college or after graduation from another degree program. The two certificates available for CRAs are Certificate in Clinical Research Associate and Certificate of Completion in Clinical Trials Management.
Certificate in Clinical Research Associate
A certificate program in clinical research associate (CRA) is aimed towards clinical research coordinators (CRC) and other professionals working in clinical research. Graduates who are clinical research associates (CRAs) may work in the medical device, biotechnology or pharmaceutical industries as opposed to hospitals or research institutions.
Admission to the certificate program in clinical research associate requires a bachelor's degree or higher. Clinical research experience is an asset. A background in the life sciences, nursing, pharmacy or medicine is preferred. Applicants who are CRCs may enroll in the program with no additional requirements.
CRAs must possess strong writing and speaking skills to communicate effectively with doctors, program participants and the other researchers. In addition to completing the program's curriculum, students need proficient computer skills, as well as being well versed in a spreadsheet application. Typical coursework includes:
- Clinical trial ethical issues
- Process of discovery and approval of drugs
- Medical terminology
- Biostatistics
- Clinical trials data management
- Monitoring plan
Certificate of Completion in Clinical Trials Management
Another option is to earn Clinical Trial Associate certification. This certificate program is generally offered through a university's extension department for CRAs, CRCs, physicians, nurses, pharmacists or other professionals interested in the field of clinical trials. Students learn about the entire process of approving new medical devices and drugs.
CRAs may enroll in this program without further requirements. Courses in this certificate program may be acceptable as continuing education credits for CRAs wishing to recertify.
A clinical trials management graduate certificate program introduces students to implementing and managing clinical trials. Typical curriculum coursework includes:
- Clinical practices and clinical trial design
- Drug development process
- Fundamentals of clinical monitoring
- Clinical research statistics
- Reporting adverse events
- Development and design of medical devices
Salary Information and Employment Outlook
The U.S. Bureau of Labor Statistics (BLS) does not keep separate statistics on clinical research associates, but their duties can be considered similar to medical scientists (www.bls.gov). Growth in employment for medical scientists or individuals working in the biotechnology industry is anticipated to be 6% from 2019-2029. According to the BLS the median salary for all medical scientists was $88,790 as of May 2019.
Students interested in becoming clinical research associates should obtain undergraduate or graduate level certificates. Clinical research associates work in the medical device, biotechnology or pharmaceutical industries and are able to be certified once they meet those requirements.