Cohortias – What does a Clinical Research Associate do?

You are the primary contact for doctors, researchers, laboratories, pharmacists, ethics committees and others such as the sponsor client.
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What does a Clinical Research Associate do?

As a Clinical Research Associate (CRA) in clinical operations you are responsible for setting up, coordinating and supervising clinical studies. You plan, prepare and help carry out clinical trials to test new or existing investigational products. This assesses their safety and benefits of use.

The work is usually done within pharmaceutical companies or CROs who conduct clinical research on behalf of pharmaceutical companies. Studies are also required within hospital departments that collect information about investigational products.

You are the primary contact for various parties including doctors, researchers, laboratories, pharmacists, ethics committees and others such as the sponsor client.

In summary, as a CRA you are responsible for ensuring that all the risks and effects of investigational products have been fully examined and approved, prior to their release on the market.

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What responsibilities can you expect as a Clinical Research Associate?

The CRA position is diverse and dynamic. Specific duties can vary depending on the company and you may work on multiple projects. A CRA will generally be required to:

  • carry out selection, initiation, monitoring and close-out visits at the participating clinical trial centres, also for logistics and coordination of the study;
  • monitor the study to check whether it has been carried out in accordance with applicable laws and regulations;
  • develop study procedures, methodology and instructions for clinical trials staff, as well as design data collection tools (case report forms);
  • manage study supplies, medication supplies and medication accountability;
  • collect, verify and finalise collected data to create reports and present results of findings to other medical staff;
  • ensure the safety and well-being of test subjects by liaising with ethics committees;
  • submission of clinical trial documents for review and approval by those ethics committees.

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