Overview
CRAs perform site initiation, monitoring and closeout visits, review source data and verify adherence to protocol and regulatory requirements on behalf of sponsors or CROs.
Monitoring Activities
They review informed consent, source documentation, investigational product accountability and adverse event reporting and resolve data queries with site staff.
Quality and Oversight
CRAs support risk based monitoring strategies, prepare monitoring reports and escalate issues to study management to protect participant safety and data quality.
Training and Certification
CRAs typically have clinical or research backgrounds and complete GCP training with experience in monitoring, regulatory documentation and clinical operations.