The Coordinator, Data Regulatory Specialist will work with the clinical research coordinators on administrative duties of trial management to coordinate regulatory aspects of clinical trials. Organizes and maintains documentation of research activities in accordance with Institutional Review Board (IRB), government regulations and study sponsors. Facilitates day-to-day activities as well as providing a timely and appropriate response to all requests from researchers, IRB, sponsors, and regulatory bodies. Other duties include, but are not limited to: 

Responsible for completing regulatory packet sent by the sponsor prior to initiation of the study. Completes documents for submission to the IRB ensuring quality, content and format adhere to institutional standards for initial applications, amendments, revisions, and annual renewals as directed by research coordinator. Maintain central files for all regulatory documents. Prepare accurate lists/databases of studies, principal investigators and research subjects, as needed for auditing purposes and provide reports to departments as requested. Schedule subject appointments in EPIC and register each research participant in the billing matrix to ensure billing of study procedures to appropriate funding source Assist the lead coordinator in internal audits of research accounts on all studies using EPIC. Maintain a database of study budgets and submit invoices accordingly. Prepare monthly, quarterly and annual reports including but not limited to number of new, active and closed studies, patient recruitment per study, compilation of fiscal information of studies. Submit quarterly research statistics into the CCSM report for Therapeutic Development Network.