•Provided leadership for the Clinical Operations project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work.•Managed the development and maintenance of clinical trials documents, processes, and systems according to trial-specific scope of work and budget with minimal guidance. Participated in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance.•Served as key site management trial-team member to internal and external partners and to the project core team (project leader, principal investigator and other functional group key representatives).•Collaborated with Clinical Operations administration to identify and oversee trial-related training and performance concerns of monitoring team members according to their individual needs; maintained awareness of level of performance and training needs; provided ongoing input to Senior Clinical Trials Lead for development of individual training plan.•Supervised and managed monitoring trial-team members’ adherence to DCRI and sponsor-specific administrative policies with guidance. Encouraged team members to attend appropriate training and meetings.•Supported the DCRI’s mission, department goals and organizational activities.

•Thorough knowledge and application of project specific protocol•Completed on site monitoring in accordance with project specific timelines•Completed travel scheduling in accordance with project specific and UBC guidelines•Attended project team meetings, departmental meetings and 1:1 with manager a minimum of monthly; responsible for content discussed during these meetings•Completed site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File per UBC/Sponsor timelines•Ensured follow-up of site issues and action items per UBC/Sponsor requirements•Entered site visits, confirmation/follow-up letters and site monitoring reports into CTMS•Completed Call Log or Telephone Contact Report detailing communication with sites per•Sponsor requirements•Monitored within EDC data entry if applicable and assists sites with DCF resolution•Completed Regulatory Binder and Investigational Product reconciliation•Maintained regular contact with assigned sites per study requirements•Completes expense reports within UBC timelines; adheres to UBC Travel Guidelines•Completed UBC and/or Sponsor SOP review and documentation within requested timelines•Completed sponsor specific training and documentation within requested timelines