Coordinate clinical trial startup from feasibility assessment through site activation, working collaboratively with PNTC Project and Business Managers and other stakeholders to track regulatory and ancillary submissions, essential study documentation, timelines, dependencies, outstanding items, and activation requirements across regulatory, operational, budget, and contract workflows. Following activation, the CRRS B will collaborate with study teams to provide ongoing regulatory support, including protocol amendments, continuing reviews, reportable events, regulatory documentation, maintenance of complete and inspection-ready study files, and coordination of monitoring visits and audits.