Overview
Companies that perform clinical trials employ clinical research associates (CRAs) to work in the regulatory approval process of new drug developments. Those certified as a clinical research associate typically work at pharmaceutical companies or contract organizations that perform outsourcing for clinical trials. A CRA is the project monitor who oversees the patient care, analyzes data and ensures that all tests are in compliance with Food and Drug Administration (FDA) regulations.
Step 1
Join one of the two organizations that provide the national examinations to become a clinical research associate. The Society of Clinical Research Associates (SoCRA) and the Association of Clinical Research Professionals (ACRP) set up examination dates and offer study guides and practice tests for applicants.
Step 2
Meet the experiential requirements of the groups prior to taking the exam. Prospective CRA candidates must have two years of professional clinical research experience or have earned a two- or four-year science degree and have one year of experience. Required work experience includes positions that have been directly involved in clinical trials that involved data collection, analysis or monitoring of trial subjects.
Step 3
Study for the exam. The tests provide a series of multiple-choice questions that cover regulatory references, clinical practice knowledge, protocol development and participant selection. Both organizations offer study guides, training courses and practice tests for a fee. Other online preparatory courses also area available to prepare candidates to pass the test.
Step 4
Register to sit for the exam. Schedules of times and places for the tests can be found on the groups’ websites. Cost to take the exam through SoCRA is $195. The Association of Clinical Research Professionals charges $525 for its certification exam for members and $855 for non-members. Certifications must be renewed every three years and run about $50 at each organization.
Tip
Ask your employer to pay for your association membership and exam fees. This is an item that can be negotiated upon hiring. While many companies encourage employees to seek certification and some will pay for the expenses, it is best to get it in writing up front.
Warning
Prepare for steep prices on review and training courses for the CRA exam. Courses to prepare students to sit for the exam can run as high as $400 or more. Try a practice exam before paying for the training because after two years or more of on-the-job training, you may be more prepared for the exam than you think.
References
Biospace.com: Biotech and Pharmaceutical News & Jobs
Society of Clinical Research Associates
Association of Clinical Research Professionals
CRA Training
