Regulatory Manager - CCC | Clinical Trials Office

Position Summary

Regulatory Manager, under the direction of the Director of Research Integrity and Compliance, will work to ensure that clinical research protocols managed within the Clinical Trials Office (CTO) are in compliance with university, state and federal regulations; serves as point of contact for CTO investigators and staff regarding specific issues associated with IRB submissions; handles and/or serves as point of contact for more complicated IRB submissions and handles other submissions as needed; maintains extensive and current knowledge of regulatory and compliance requirements of the IRB, FDA, NIH, and other agencies; identifies training and educational needs regarding clinical research compliance; ensures timely submission of all appropriate paperwork for review by appropriate agency; communicates with sponsors of any research project to assure compliance; interfaces with various university departments to coordinate and effectively compile all appropriate data relevant to the conduct of a trial; manages and oversees development of high quality IRB submission packets for protocols and submissions to the FDA and other entities as needed; monitors distribution of IRB approved documents to relevant university protocol holders; tracks progress of a protocol's review; oversees maintenance of files on all studies; attends meetings to provide regulatory updates and advise research staff of new or changed regulations; is available to meet with sponsors, investigators and research staff as needed; serves as principal contact for the CTO to the IRB; participates in monitoring visits and audits; directs development of SOPs and relevant research office processes and reviews submissions as needed to ensure compliance with all regulations; oversees periodic internal audits to ensure compliance with Good Clinical Practice and provides guidance as needed; interviews, trains, supervises and evaluates regulatory staff; performs other duties as assigned.

Job Requirements

Bachelors Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; Masters degree in a relevant field desired; 5 years of experience in a clinical research or administrative capacity working on clinical research projects required; knowledge of state, federal amp; industry sponsors clinical research regulations, guidelines amp; compliance required; experience in protocol development preferred; experience of university research regulatory policies and procedures preferred; experience developing and preparing regulatory documents preferred; ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification required.

As one of only 50 designated comprehensive cancer centers in the nation, The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital and Richard J. Solove Research Institute is dedicated to the creation of knowledge in laboratory, clinical and population-based cancer research. We apply those discoveries to develop more effective approaches to cancer prevention, diagnosis, and therapies providing tomorrows standard of care today. A Cancer-Free World Begins Here.