A clinical research associate (CRA) runs clinical trials to test drugs for their effectiveness, risks and benefits to ensure they are safe to allow on to the market. They may work on new as well as existing drugs and are usually employed by either a pharmaceutical company or a contract research organisation (CRO) which works on behalf of pharmaceutical companies.
The CRA will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial.
Clinical trials may be carried out 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 drug to monitor safety and side effects.
Typical work activities
Tasks carried out by a CRA vary depending on the employer but will typically 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 report 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;
identifying and assessing the suitability of facilities to be used as the clinical trial site;
identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site;
liaising with doctors/consultants or investigators on conducting the trial;
setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards;
monitoring the trial throughout its duration, which involves visiting the trial sites 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 and filing and collating trial documentation and reports;
ensuring all unused trial supplies are accounted for;
closing down trial sites 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.
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