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Position Summary
Senior Regulatory Compliance Officer provides regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the OSUCCC Clinical Trials Office.
Responsibilities
Assists the Regulatory Manager with the oversight and monitoring of the regulatory research compliance function across all disease teams managed by the clinical trials office. (CTO).
Serves as the subject matter expert for all regulatory compliance officers within the departments, reviews regulatory documents prior to submission to sponsors, IRB, FDA to ensure compliance.
Answers questions and provide technical support to junior members on the team. Provides coverage/back up as needed for Regulatory manager and/or team members.
Manages complex submission and assisting junior team members with the process.
Participates in the development of SOPs and Processes for the regulatory team to stay current with the changing regulatory requirements and training.
Participates in the creation and delivery of on boarding and educational training programs, tools and materials for CTO staff, and investigators.
Provides regulatory guidance, direction and support to all members of research team.
Stays current on legislation, rules, regulations, procedures, and development; educate physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients.
Work with CTO Managers and coordinators as needed to ensure understanding of study protocols.
Job Requirements
Bachelor’s degree in relevant field required or equivalent combination of education and experience; Master’s degree in a relevant field desired; clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) required; 3 – 5 yrs. of experience in a clinical research or administrative capacity working on clinical research projects required; considerable knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required; experience and knowledge of federal & industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical research setting desired; experience in protocol development desired.
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 tomorrow’s standard of care today. A Cancer-Free World Begins Here.
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
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