Research Regulatory Coordinator - RI Gene Therapy

Job Description Summary 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. Confirm 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 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 Requirement Associates degree or equivalent experience in medical/science field. Licensure Requirement (not specified) Certifications (not specified) Skills 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. Experience Six months research experience, preferred. Physical Requirements Occasionally: Bend/twist, Driving motor vehicles (work required) *additional testing may be required, Reaching above shoulder, Squat/kneel Frequently: Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Sitting, Standing, Walking Continuously: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing – Far/near Additional Physical Requirements Performed But Not Listed Above: (not specified) “The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet” #J-18808-Ljbffr Nationwide Children's Hospital