Clinical Research Associate (CRA)
Clinical Research Associate also known as monitor is employed by either a pharmaceutical company or a contract research organization (CRO) which works on behalf of pharmaceutical companies. Clinical trials may be carried out at various phases, trials on patients with a disease, and studies conducted after the launch of a new drug to monitor safety and side effects. The CRA will be involved in all stages of the clinical trial, including identifying an investigation site and setting up, initiating, monitoring and closing the trial upon completion or termination.
Roles and Responsibilities of CRA:
- 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. Training the study staff in standard operating procedure for the clinical trials as per applicable regulatory requirements.
- Verify that investigator and investigator’s team are adequately trained and comply with the protocol.
- Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.
- Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.
- Source data verification
- Informed consent form review, case report form review, investigational drug accountability, and adverse event review.
- Ensuring all unused trial supplies are accounted for.
- Writing visit reports, filing and collecting trial documentation and reports.
Skills:
Skills required for CRA job profile are,
- Excellent communication skills (both written and oral) and the ability to build effective relationships with trial centre staff and colleagues
- The ability to motivate others
- An eye for detail
- Ability to multi-task and think on your feet
- Good organizational, IT and administrative skills – job involves lot of documentation and recording of information through computerized processes such as clinical trial management systems and electronic data capture.
Prospects:
Depending on experience in the fields of health-care and clinical research as well as areas of interest, CRAs can aspire to be
Lead CRA.
Head of Clinical Research.
Project Manager.
Director of Clinical Operations.
The work of a Clinical-Research Associate opens career opportunities in the pharmaceutical research-and-development sector for positions in pharmacovigilance, regulatory affairs, and marketing.