Clinical research associate
Clinical research associate (klin-i-kal ree-surch uh-soh-see-eyt, from Latin clinicus meaning "bedside" and associare meaning "to join") is a healthcare professional who performs many activities related to clinical trials. They are often employed by Clinical Research Organizations (CROs) or pharmaceutical companies.
Role and Responsibilities
A Clinical research associate (CRA) is involved in all stages of the clinical trial, including the design, implementation, and monitoring. They ensure that the trial is conducted in accordance with the Good Clinical Practice (GCP) guidelines and that the data collected is reliable and accurate.
The CRA's responsibilities include:
- Developing and writing trial protocols
- Presenting trial protocols to a steering committee
- 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
- Locating and assessing the suitability of facilities at a study centre
- Liaising with doctors/consultants or investigators on conducting the trial
- Setting up the study centres, which includes ensuring each centre has the trial materials
- Monitoring the trial throughout its duration, which involves visiting the study centres on a regular basis
- Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data verification (SDV)
- Collecting completed CRFs from hospitals and general practices
- Closing down study centres on completion of the trial
- Discussing results with a statistician
- Writing visit reports and filing and collating trial documentation and reports
- Ensuring all unused trial supplies are accounted for
- Archiving study documentation and correspondence
- Preparing final reports and occasionally manuscripts for publication
Education and Training
A CRA typically has a degree in life sciences, nursing, or a related field. They also usually have experience in clinical trials. Training for a CRA role often includes courses in medical ethics, pharmacology, and clinical practice guidelines.
See Also
- Clinical trial protocol
- Clinical data management
- Clinical research coordinator
- Pharmaceutical industry
External links
- Medical encyclopedia article on Clinical research associate
- Wikipedia's article - Clinical research associate
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