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. Education: High School diploma or equivalent, and Medical Terminology Skills: Excellent organizational, communication and computer skills Years of Experience: 2 years’ experience in healthcare and clerical skills with data entry License: N/A Certification: Must complete CITI and IATA training within one month of hiring PREFERRED QUALIFICATIONS Education: Nursing Assistant, Clerical Skills Skills: Excellent skills in computer data entry, EMR, and programs such as MS Word and Excel. Working knowledge of clinical trials. Years of Experience: 2-4 years’ experience in healthcare with clerical experience in data entry. The above list of accountabilities is intended to describe the general nature and level of work performed by the positions; it should not be considered exhaustive. Qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, religion, sex/gender (including pregnancy), sexual orientation, gender identity or gender expression, age, physical or mental disability, military or protected veteran status, citizenship, familial or marital status, genetics, or other status protected by applicable law. Equal Opportunity Employer/Drug-Free Workplace **Requisition ID:** 91162