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Clinical research associate: Job description and activities

Job description

A clinical research associate (CRA) sets up, monitors and completes clinical trials.

A clinical trial is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. Trials need to be carried out before a product reaches a hospital or the shelves of the local pharmacy. They are undertaken at various stages, or 'phases', and include: trials on healthy humans; trials on patients with a disease; and studies conducted after the launch of a new product to monitor safety and side effects during large-scale use.

Clinical trials are conducted by pharmaceutical companies or contract research organisations (CROs) on their behalf.

Typical work activities

Typical work activities include:

• developing and writing trial protocols (outlining the purpose and methodology of a trial);
• presenting trial protocols to a steering committee;
• designing data collection forms, known as case record forms (CRFs);
• coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;
• managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs;
• locating and assessing the suitability of facilities at a study centre;
• liaising with doctors/consultants (or investigators) on conducting the trial;
• setting up the study centres, which includes ensuring each centre has the trial materials and training site staff to trial-specific industry standards;
• training site staff to industry standards;
• monitoring the trial throughout its duration, which involves visiting the study centres on a regular basis;
• verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);
• collecting completed CRFs from hospitals and general practices;
• writing visit reports;
• filing and collating trial documentation and reports;
• ensuring all unused trial supplies are accounted for;
• closing down study centres on completion of the trial;
• discussing results with a medical statistician, who usually writes technical trial reports;
• archiving study documentation and correspondence;
• preparing final reports and occasionally manuscripts for publication.

The job of a clinical research associate (CRA) can vary tremendously. In some companies, you would be involved in the whole process: sitting down with the doctor who has the idea for a trial; working out a protocol; and writing up reports after the analysis has been done. In others, a medical adviser would initiate the trial, and the CRA would become involved in collecting data once the trial had been set up.

AGCAS

Written by Eleanor Stanley, The College of Law

Last updated:

November 2008

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