Under the supervision of the Accelerated Study Start-Up Program Manager, we are seeking a **_Regulatory Specialist II_** who will serve as a central resource for faculty conducting clinical research. The Regulatory Specialist II will be assigned to a dedicated portfolio of clinical divisions and their investigators working to facilitate study startup and maintenance of commercially sponsored clinical trials. Startup activities include coordination of internal partners (study teams, central research administrative teams) and external partners (commercial sponsors, CROs), feasibility surveys, coordination and initiation of contract and budget activities, and initial applications to the IRB and other regulatory agencies. Maintenance activities include regulatory activities over the duration of the study such as creating IRB submissions such as change in research, continuing review, protocol event report, etc., and managing required documents in the electronic regulatory binder ensuring ...