Thursday, 23rd November 2017
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CLINICAL RESEARCH ASSOCIATE

Clinical research associates (CRA) work alongside doctors in clinical trials of new medicines and treatments intended for use on humans. All medical products need to be fully tested and approved before hitting the shelves. Clinical trials are long-term experiments testing the safety and efficacy of new pharmaceutical products and medicines on volunteers or patients, after the products have passed the non-clinical testing.

CRAs will see the clinical trial of these products through all the different stages. They will set up, monitor and finish the clinical trials, sometimes continuing after the products have been released for use. There are different stages of the trials that the CRA will supervise: testing the product on a healthy human; testing on sick patients; and following up on the product after widespread usage.

Typical tasks of clinical research associates might include:

  • Liaising with doctors about trial ideas, aims and protocols
  • Developing and writing trial plans and methodology
  • Presenting trial protocols to relevant boards and ethics committees
  • Briefing the research team and trial investigators
  • Setting up study centres
  • Monitoring trials throughout
  • Collecting and analysing the data
  • Filling in case record forms (CRFs)
  • Accounting for all facilities, equipment and utensils used
  • Signing off on the trial and closing it down
  • Discussing results of the trials with those who write the reports and relevant documents

CRAs can be employed by pharmaceutical companies or by research organisations working on a contractual basis. The roles of CRAs can vary depending on the type of employer as well as the type of trial. Trials can vary in length and complexity, so working conditions often differ.

CRAs may not always be involved in the entire process of discussing the trial idea with the doctors before being approved, but they will most often be responsible for seeing the trial through from start to finish.