What is CRA ?

A Clinical Research Associate, also known as a Monitor, is an individual that oversees the progress and conduct of a clinical trial. A clinical trial is usually implemented by physicians at a hospital, clinic, or physician's office. The CRA is required to oversee the initiation, progress, and conduct of the clinical trial to ensure the scientific integrity of the data collected, and the protection of the rights, safety, and well-being of human study subjects.

• Monitoring that the physician adheres to Good Clinical Practices and the study protocol.


• Verifying the documentation of the informed consent process for each study subject;


• Ensuring that non-serious and serious adverse experiences are properly documented and reported.


• Reviewing the case report form against the subject's medical record for completeness and accuracy;


• Ensuring the filing and maintenance of the required regulatory documents.


• Performing study drug accountability;