This position also applies experience using a clinical trial management system (CTMS) and electronic regulatory systems for protocol and regulatory document management, with responsibility for creating, maintaining, and scheduling portfolio reports that keep key stakeholders informed of study progress, regulatory milestones, risks, and overall portfolio status. The Senior Research Regulatory Specialist applies advanced experience supporting Phase 1 research, Independent Review Board (IRB), Institutional Biosafety Committee (IBC) submissions, and a broad range of institutional research committee reviews to guide complex study activation and ongoing regulatory maintenance.