• Initiated 19 sites by making sure that the regulatory requirements were met and properly documented as per CVC standards and GCP guidelines • Kept track of all outstanding queries on activated sites and helped in resolution of these queries in RDC• Stored and maintained regulatory documents for 19 sites in electronic trial master files (eTMF) as per regulatory requirements and to ensure easy accessibility. • Updated and maintained various systems like CTMF, STMF, RDC, IRT and CTMS to provide easy traceability of trial project progress to all stakeholders. • Looked after the change management process for site personnel, making sure that qualification, necessary training and documentation were complete. • Initiated and completed the process of study drug activation for each site including completing of activation checklist as a first reviewer and completion of CTSI form • Updated the CTMS-Milestones, status history, documents, conversation logs and trainings sections of the sites• Coordinated with CRA to facilitate site monitoring visits, assisted in closing monitoring action items in the Clinical Trial Management System (CTMS), prepared and sent PMV checklists prior to the site monitoring visit, informed the sites about status of any outstanding issues • Monitored progress and issues related to different sites and periodically reported to Clinical Trials Project Lead • Reviewed and monitored completion and accuracy of regulatory documents for 19 sites across Canada ensuring they met regulatory requirements and International Council for Harmonization (ICH)/Good Clinical Practice (GCP) guidelines • For the ease and efficiency of operations, developed several processes including PMV checklists, CTMS Action Items, Training Summaries, and RDC completion