• 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.

Develop and execute site engagement strategies, build strong relationships with clinical trial sites, manage study challenges, and collaborate with internal teams to ensure successful clinical trial execution and compliance.

Serve as the primary liaison between departments, optimizing clinical workflows, conducting audits, and educating staff on compliance and coding to enhance operational efficiency and financial performance.

Provide diagnosis-specific nutrition education and counseling, create educational materials for employees, and ensure timely communication and documentation while serving as a subject matter expert in nutrition therapies.