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    Solution Of The Year

Clinical Research Associate

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Clinical Research Associate

A clinical research associate (CRA) runs clinical trials to test drugs for their effectiveness, risks and benefits to ensure that they are safe to allow on to the market. 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.

Responsibilities include –

  • Developing and writing trial protocols (outlining the purpose and methodology of a trial);
  • 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;
  • Ensuring all unused trial supplies are accounted for;