What is a CRA?
A Clinical Research Associate supervises and monitors the progress o clinical trials on behalf of a sponsor.
What is a Clinical Trial?
Clinical Trials are experiments or observations done in clinical research Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about new biomedical or behavioral interventions that warrant further study a comparison.
What they do all day?
Where there's a clinical trial, clinical research associates are making sure it's going the way it should. That means monitoring procedures and results and making sure that researchers are following proper protocols at every step.​
What makes it great?
Since there are so many different types of clinical trials, the work environment can be dynamic with tasks varying from day to day. CRAs can specialize in a particular subject area, or go for a broad base of knowledge and hop from topic to topic. And growth potential is strong: As personalized medicine becomes more common, clinical trials will increasingly be needed to make sure drugs and devices work properly.
How to get the job?
A bachelor's in any field but preferably in science, sociology or psychology is a good foundation, as is experience in a clinical trial environment or in health sciences. Minimum requirement is a bachelors degree in any field from any school!
What's the catch?
Most CRA jobs require at least some travel regionally, if not nationally or internationally, which can mean long hours and lots of time away from family.
AM I QUALIFIED?
A bachelor's in science, sociology or psychology is a good foundation however science based degrees are not mandatory. Experience in a clinical trial environment or in health sciences is also valuable.
Some employers look for a CRA certification, such as the one offered by the Association of Clinical Research Professionals (ACRP) as well.
Some employers look for a CRA certification, such as the one offered by the Association of Clinical Research Professionals (ACRP) as well.
HOW TO BECOME A CERTIFIED CLINICAL RESEARCH ASSOCIATE
The CCRA® eligibility criteria define the minimum experience required before a CRA can apply for the program. It is important to compare the CRA eligibility criteria with your career and educational experiences to self-determine your eligibility before submitting an application and payment. All applications must undergo a formal review process to determine an applicant’s eligibility to sit for the exam.
CRA Certification Eligibility Requirements
In order to be deemed eligible to take the CCRA® exam, applicants for the CCRA® credential must be able to provide evidence through a job description, detailed CV, or other documentation that they:
Work independently of the investigative staff conducting the research at the site or institution. This means they do not report to the PI or site manager and that they do not have the ability to change or manipulate data, and; Work on behalf of the sponsor. This means that they are contracted by the “sponsor” to perform an independent monitoring function. The “sponsor” can be a pharmaceutical or device company, a granting agency, a university department, a physician, etc., and;
Perform all of the CCRA® essential duties as detailed below for a required minimum number of hours. Hours performing the CRA essential duties can include hours documented up to the date of the exam and/or through previous employment. The required number of hours is dependent upon one’s educational background.
The CRA Certification Handbook has complete information on eligibility requirements.
CRA Essential Duties
CCRA® Eligibility Requirements
As defined by the Academy, and determined through ACRP’s 2015 Job Analysis Survey, clinical research associates who are eligible for CRA Certification must document cumulative performance of each of the following essential duties during the dates of employment listed on the application:
Verify that the research site investigator(s) and study personnel are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements to ensure protection and ethical treatment of human subjects;
Ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC;
Perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.)
Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools);
Ensure accountability of Investigational Product and related supplies are performed, when appropriate;
Ensure complete reporting and proper documentation of monitoring activities
Conduct routine monitoring visits (on site or remotely) independently from the investigative site study staff;
Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.
The above essential duties must have been performed for a cumulative 3,000 – 6,000 hours, depending on the applicant’s education background, as shown here.
At least one of the eligibility requirement options below should be met before applying for the CCRA® program.
Option 1: Bachelor’s Degree (or higher)
Minimum Hours Performing Essential Duties: 3,000 hours* Required Documentation of Performed Essential Duties: Detailed CV/resume and job description
