Beginner CRA

CRA BASICS, TIPS AND CAREER DEVELOPMENT FOR ENTRY LEVEL CLINICAL RESEARCH ASSOCIATES OR THOSE INTERESTED IN BECOMING CLINICAL RESEARCH ASSOCIATES

What is A Clinical Research Associate?

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A Clinical Research Associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP). ICH GCP uses the term “Monitor” instead of CRA, both terms are used interchangeably in the field. The main task of a clinical research associate is to monitor clinical trials. He or she may work directly for the sponsor company of a clinical trial (Pharmaceutical Company), as a hired contractor or for a Contract Research Organization (CRO). A clinical research associate confirms that the clinical trial sites are compliant with the clinical trial protocol, checks site activities, makes on-site visits, reviews Case Report Forms (CRFs) against source documents and communicates with clinical research investigators and study coordinators. A clinical research associate is usually required to possess an academic degree in Life Sciences and needs to have a good working knowledge of Good clinical practice and local regulations.

-Sara

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