• Conduct qualification, initiation, interim monitoring, and close-out visits in accordance with the Monitoring Plan • Ensure investigational sites remain compliant with the approved protocol, regulatory requirements, and Sponsor SOPs • Perform source data review and verification to ensure accuracy, completeness, and traceability of clinical data • Review and ensure timely reporting of adverse events and device deficiencies • Support preparation of FDA Annual Reports and regulatory submissions as applicable • Maintain and reconcile TMF/eTMF documentation to ensure inspection readiness • Provide site training on investigational plan requirements and study procedures • Collaborate with Regulatory Affairs and Data Management to resolve data and compliance issues • Escalate protocol deviations, compliance concerns, or site performance issues as appropriate • Support internal and external audit readiness activities