A Clinical Research Associate (CRA) is a healthcare and research professional responsible for monitoring and managing clinical trials to ensure they are conducted according to study protocols, regulatory guidelines, and ethical standards.
Role & responsibilities
* Monitor clinical trial sites and ensure compliance with protocols, Valuable Clinical Practice (GCP), and regulatory requirements.
* Review study documents, source data, and case report forms (CRFs).
* Conduct site initiation, monitoring, and close-out visits.
* Verify the accuracy and completeness of clinical data collected during the study.
* Ensure patient safety and proper reporting of adverse events.
* Coordinate with investigators, study coordinators, sponsors, and other stakeholders.
* Maintain trial documentation and prepare monitoring reports.
* Support audit and inspection readiness throughout the study.