PURPOSE OF THE JOB Responsible for the effective management and implementation of clinical trials in the Clinical Research Unit (CRU) in compliance will all relevant Standard Operating Procedures (SOPs), Good Clinical Practice Guidelines (GCP) and relevant regulatory requirements. Serves as the primary liaison between CRU study team and Sponsor on operational matters, Sponsor representatives (e.g. monitors, vendors) and Ethics/Institutional Review Board (ERB). CORE JOB TASK Study Management Manages study implementation from planning to closeout. Liaises with the sponsor and site study team during the development phase of the protocol to ensure consistency and operational viability of a protocol. Provides leadership in the review and development of study-related documents such as protocol, informed consent document, case report forms, source document worksheets, and CRU tools for study compliance (e.g. activity schedule and compliance checklist). Coordinates with CRU team in the discussion of study risk assessment and oversees implementation of relevant mitigation plans. Manages process for study specific subject safety management. Responsible for maintenance and completeness of investigator trial master files. Assists with the financial tracking of study activities and monitoring of study budget. Serves as the primary liaison between CRU study team and external Sponsors, ERB and monitors. Coordinates with sponsor, and/or monitor on the timelines for site training, site initiation, site monitoring and close-out visits. Leads site study meetings and coordinates between sponsor and site study team on study requirements. Liaises with CRU operations team on logistics planning, study scheduling and training needs of site study team. Responsible for managing study related external vendors and collaborators (e.g. conduct kick off meetings), or overseeing similar external engagements lead by study team members as appropriate to each function. Tracks study timelines and provi