Research Regulatory Coordinator - RI Pulmonary Med

Overview Assists with the administrative components required to ensure compliance in the regulatory processes for a clinical research project. Essential Functions Creates the initial study administrative binder required for the clinical research project. Maintains study binders, files documents timely, and reviews binders prior to monitor visits to ensure completeness. Prepares, submits, and maintains IRB‑related documents. Ensures accuracy and congruency between IRB, regulatory documents, study documents, and grants system. Confirms all investigators, staff, and departments to be used for the study. Collects CVs and licenses and confirms that IRB training requirements have been met. Maintains a master file of current CVs and licenses. Collects and stores regulatory documents required by the clinical research project in compliance with federal and local regulations and guidelines. Keeps site documents up to date (IRB roster, lab certificates, etc.). Oversees document retrieval and archival process at study termination. Works with marketing and research staff to ensure studies utilizing recruitment tactics are posted appropriately. Education and Experience Associate’s degree or equivalent experience in a medical or science field. Six months of research experience preferred. Licensure and Certifications Not specified. Skills and Knowledge Strong administrative skills and attention to detail. Excellent computer skills. Knowledge of medical terminology and diseases. Ability to multi-task; customer‑focused personality with strong organizational and prioritization skills. Working knowledge of IRB and regulatory processes and systems. Current knowledge of federal regulations (FDA, GCP, NIH, DHHS, ICH GCP) and study protocols. Physical Requirements Occasionally: bend/twist, drive motor vehicles (work required), reach above shoulder, kneel/squat.Frequent: lift/carry 0–20 lbs, push/pull 0–40 lbs.Continuous: audible speech, computer skills, decision making, depth perception, neck movements, hand use, hearing acuity, data interpretation, peripheral vision, problem solving, repetitive hand/arm use, vision far/near. Equal Opportunity Employer EOE M/F/Disability/Vet. #J-18808-Ljbffr 10 Nationwide Children's Hospital