-Site management for multi-center clinical trials including study start-up, maintenance and close-out activities -Performing and documenting site initiation visits, interim monitoring visits and site close-out visits including source data verification (SDV), documenting, reviewing and monitoring site reports-Training risk-based monitoring approaches-Creating and maintaining electronic Trial master File (eTMF)-Issuing and tracking protocol deviations and violations-Identifying and resolving performance issues and procedural gaps by conducting Root Cause Analysis; educating and retraining sites as necessary and employing Corrective and Preventive Action plans when appropriate-Maintaining Clinical Trials Management Systems (CTMs) for sites and studies including payment, study metrics and reports-Authoring training materials and training junior staff-Ensure reporting of safety issues (SAEs) for sponsor and applicable governing bodies-Conduct all research procedures in compliance with federal regulations (CFR), institutional/departmental guidelines (including the FDA), and standards of Good Clinical Practice (GCP) -and International Conference of Harmonization (ICH)