• Oversight of day-to- day operations of the Clinical Research Department.• Provides supervision to the Clinical Research Nurse Manager and Regulatory and Project Manager.• Participates in hiring and training of Clinical Research Coordinators, Regulatory Specialists, and support staff.• Manages business aspects of studies including study budget negotiation and contracts.• Work closely with Principal Investigators, Clinical Research Team, Ancillary Departments, Billing Compliance, Research Compliance, Research Finance, Research Legal, Sponsors, Contract Research Organization, and Study Monitors from Study Start up to Study Close out.• Ensures all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state, and federal laws, regulations, guidance, policy and procedure developed by the Institutional Review Board (IRB), Food and Drug Administration (FDA), and Code of Federal Regulations (CFR).• Designated Clinical Research Project Manager on all Investigator/Physician Initiated Research Studies, providing consultative services including, but not limited to assisting with IND development, application, and maintenance, informed consent development, study budget creation including staffing assessment, logistics and feasibility of protocol within the department and ancillary services required per protocol, and act as liaison with the Institutional Review Board and other Research Departments as required.• Project Manager for SH JDRF REPAIR T1D, “Combination Therapy with Sitalgliptin (DPP 4 Inhibitor) and Lansoprazole (Proton Pump Inhibitor) to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes”. Responsibilities with this multi-site study included protocol optimization, procurement of study drug, budget creation, site feasibility and selection, as well as oversight of data monitoring.