• 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 • 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 • Draft and deliver confirmation, follow-up, and monitoring visit reports (SQV, SIV, IMV, COV) • Maintain regular communication with the Lead RCRA (LRCRA) to report on site progress and resolve issues • Assess site readiness and resourcing (personnel, facilities, supplies) for trial conduct • Collaborate with vendors (e.g., central lab, imaging core) to resolve operational issues • Lead or participate in co-monitoring, oversight, and training visits as needed.