Clinical drug research is a competitive but growing field and work experience in a scientific or healthcare environment is crucial for a job as a clinical research associate
As a clinical research associate (CRA), you’ll run clinical trials to test drugs for their effectiveness, risks and benefits to ensure that they are safe for the intended use.
You’ll work on new and existing drugs and 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.
Tasks vary depending on your employer and level of experience. However, you’ll typically need to:
- develop and write trial protocols (outlining purpose and methodology)
- present trial protocols to a steering committee
- design data collection forms, known as case report forms (CRFs)
- coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
- manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
- identify and assess the suitability of facilities to use as the clinical trial site
- identify/select an investigator who will be responsible for conducting the trial at the trial site
- liaise with doctors, consultants or investigators on conducting the trial
- set up the trial sites – ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
- train the site staff to trial-specific industry standards
- monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
- verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
- collect completed CRFs from hospitals and general practices
- write visit reports and file and collate trial documentation and reports
- meet with team members to discuss on-going trials, results and any trends or adverse events
- ensure all unused trial supplies are accounted for
- close down trial sites on completion of the trial
- discuss results with a medical statistician, who writes technical trial reports
- archive study documentation and correspondence
- prepare final reports and occasionally manuscripts for publication.