Regulatory Compliance Officer – Clinical Trials

Job Description: • Assures that research protocols of the OSUCCC Clinical Trials Office (CTO) are in compliance with University, state and federal regulations • Ensures timely submission of all appropriate paperwork for review by appropriate agency • Collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included • Conducts detailed reviews of assigned protocols and informed consent forms prior to IRB review • Communicates with all CTO research projects sponsors to ensure compliance • Develops IRB submission packets for protocols, including writing of abstract and drafting of informed consent forms • Attends meetings; serves as principal contact from CTO to regulatory agencies including FDA and IRBs • Provides regulatory updates and guidance to investigators and research staff of new or changed regulations Requirements: • Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required • One year experience in research or administrative capacity working on research projects • Knowledge of research regulations, guidelines and compliance issues required • Experience developing informed consent documents and preparing regulatory documents desired • Experience and knowledge of IRB and federal or industry sponsor processes and requirements preferred Benefits: • Health insurance • Tuition assistance for employees and their dependents • State or alternative retirement options with competitive employer contributions Apply tot his job