Clinical Research Associate

Clinical Research Associate (CRA) is a professional who plays a crucial role in the field of clinical research. The primary responsibility of a CRA is to monitor clinical trials, ensure the rights and well-being of human subjects are protected, and the reported trial data are accurate, complete, and verifiable from source documents.

Role and Responsibilities

A Clinical Research Associate is involved in various stages of a clinical trial, including its design, initiation, conduct, and reporting. Their 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, responsible for safeguarding the rights, safety, and well-being of all trial subjects
• Locating and assessing the suitability of facilities at a study center
• Liaising with doctors or investigators on conducting the trial
• Setting up the study centers, ensuring each center has the trial materials
• Monitoring the trial throughout its duration, which involves visiting the study centers on a regular basis
• Verifying that data entered onto the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• Collecting completed CRFs from hospitals and general practices
• Closing down study centers 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

Qualifications and Skills

A Clinical Research Associate should have a degree in life sciences, nursing, or medical sciences. They should have a good understanding of Good Clinical Practice (GCP) guidelines, including local regulatory requirements. CRAs should also have excellent communication skills, attention to detail, and organizational skills. Experience in clinical trials is often required, and knowledge of the therapeutic area of the trial is beneficial.

See Also

• Clinical Trials
• Good Clinical Practice
• Clinical Research
• Clinical Research Coordinator
• Clinical Research Organization