With generous pay and great scheduling flexibility, becoming a clinical research associate is an excellent career for individuals who are passionate about research.
Organization and communication are also essential aspects of this career, as you’ll be working with and supervising teams of researchers as they conduct the actual studies.
What Does a Clinical Research Associate Do?
A clinical research associate is someone who plans, coordinates, and supervises research and clinical trials. While the clinical research associate may not be directly conducting the research trial or experiment, organizations hire these individuals to monitor the trial to ensure that the highest-quality research is being conducted and that safety and the clinical trial research protocols are being followed.
Clinical research associates (CRAs) may also be called clinical monitors or clinical trial monitors. They adhere to good clinical practice (GCP) guidelines, which are standards followed by international organizations conducting clinical research trials.
How Do I Become a Clinical Researcher in the USA?
Certification as a clinical research associate is offered by The Association of Clinical Research Professionals (ACRP), but there are high standards set by this organization for individuals looking to take this exam. There are a few pathways someone can take to become eligible to take this entry-level exam, which we will explain here.
The first option for eligibility in taking the certification exam is to already have a certification through The Association of Clinical Research Professionals (ACRP), in which case the organization awards applicants 1,500 hours of professional experience counted toward the mandatory 3,000 professional hours of experience.
The second option that you may be eligible for applies to those who have completed a research degree from a Council on Higher Education Accreditation (CHEA) program. ACRP awards students with half of the required professional hours of experience needed to take the CCRA examination.
Of course, the final way to gain eligibility for taking this exam is to have completed 3,000 hours of relevant professional experience. Keep in mind that if you happen to have a prior credential with ACRP and have completed a CHEA accredited clinical research program, you’ll not receive an automatic 3,000 hours of substituted work experience. ACRP only allows its applicants to utilize one of the three pathways, which means that, at a minimum, you’ll have to obtain 1,500 hours of clinical research experience. By the way, all this professional experience has to be within the last decade, as any experience earned more than ten years ago will not be counted.
Once you’ve obtained the necessary experience, it’ll be time to take the entry-level certification exam. The ACRP entry-level certification tests for CRAs are held in the fall of each year. Those that sign up for the test in May or June of the test year receive a discounted early bird rate. Additionally, becoming a member of this organization can be advantageous, as member and non-member rates for the exam can differ by more than $100.
The certification exam itself is composed of 125-multiple choice questions, of which 1/5th of the questions won’t count toward the candidates’ total score. The test covers six core areas, including Scientific Concepts and Research Design, Ethical and Participant Safety Considerations, Product Development/Regulation or Investigational Product/Device Regulation, Clinical Trial Operations (GCPs), Study and Site Management, and Data Management and Informatics.
If you’re feeling overwhelmed by all of this information, don’t worry too much, as you’ll likely have a good grasp on the test materials when your test day comes along because of the 1,500 to 3,000 hours of clinical trial experience you’ll need before even applying to this exam. You’ll also have three hours to complete this exam, which means you’ll have more than a minute to answer each multiple-choice question.
How to Prepare for the Certification Exam
To ensure that you’ll pass this exam on the first attempt, candidates are encouraged to study the five ICH Guidelines and the Declaration of Helsinki. The five ICH Guidelines include Guideline for Good Clinical Practice E6(R2), Definitions and Standards for Expedited Reporting E2A, General Considerations for Clinical Trials E8, Statistical Principles for Clinical Trials E9, and the Clinical Investigation of Medicinal Products in the Pediatric Population E11.
The ACRP also provides applicants the ability to take a pretest that consists of 50 previously used test questions with the correct answer listed. They also offer additional preparation material, which you can purchase on their website.
How Do I Become a Clinical Research Associate in Canada?
Individuals located in Canada wishing to know how to become a CRA will have to go through a similar process to become certified. Instead of the ACRP, CRAs wishing to become certified will go through the Canadian Association of Clinical Research Specialists (CACRS), which offers certification as a clinical research specialist (CRS).
The Canadian CRS requirements are a little different from the ACRP exam in that those with doctorate degrees in science are only required to have two years of experience. In comparison, bachelor’s degree holders are expected to have three years of research experience.