The Senior Regional Clinical Research Associate (SRCRA) serves as the primary liaison to clinical trial sites participating in Corcept-sponsored studies. This role is responsible for managing site activities across all stages—qualification, initiation, monitoring, and close-out. The SRCRA ensures patient recruitment, enrollment, and overall site performance are aligned with GCP, ICH guidelines, and Corcept SOPs.

Responsibilities:

Site Monitoring & Oversight

• Conduct qualification, initiation, interim, and close-out visits both remotely and on-site
• Act as the main point of contact for site staff and ensure consistent communication throughout the study
• Monitor site performance, including recruitment, enrollment, source data verification, protocol adherence, safety reporting, and data query resolution
• Meet with the Principal Investigator during visits to discuss findings and next steps
• Train site staff on protocol requirements, source documentation, and CRF completion
• Prepare and submit visit reports and correspondence in accordance with the monitoring plan and SOPs

Regulatory and Documentation Compliance

• Responsible for the collection and maintenance of regulatory documentation
• Ensure accurate and timely IRB/EC submission, communication, and approvals are maintained within the Investigator Site File (ISF)
• Reconcile ISF contents with Corcept’s eTMF to ensure completeness and accuracy
• Responsible for conducting Investigational Product (IP) accountability and reconciliation, document destruction and return, and monitor re-supply and storage conditions
• Ensure timely and appropriate SAE reporting and submission to IRBs

Site Communications & Relationship Management

• Draft and deliver confirmation, follow-up, and monitoring visit reports (SQV, SIV, IMV, COV)