• Responsible for performing investigative site recruitment/feasibility, site project training, remote clinical data monitoring and resolution, site progress status tracking, in-house site management, documentation filing, and other duties in accordance with Sponsor and/or UBC requirements. • Performs essential document collection and review for site start up and initiates in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and good documentation practices. • Demonstrates ability to successfully lead and mentor CTS staff, take on high level tasks as delegated by Project Manager/Functional Manager, and escalate and mitigate risk as appropriate. • Manage Regulatory and Institutional Review Board (IRB) Activities: Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission. • Conduct regulatory packet submissions to clients for site approval and drug release. • Create and review project planning documents including but not limited to Essential Document Review Plan (EDRP), Site Management Plan, and Project Plan. • Train sites on their continued contractual, regulatory, and legal obligations. • Evaluate sites to determine interest, adequate subject population, facilities, staff and qualifications to conduct a study. • Manage site relationships to ensure positive interactions through routine site contact. • Ensure sites meet subject safety reporting regulations: subject safety information is disseminated appropriately by evaluating consistency, quality and timeliness of serious adverse events reported by the site and submission to the IRB. • Track study activities, milestones, document receipt, and payment status in CTMS.