Regulatory Compliance Officer – Clinical Trials

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The Ohio State University, Main Campus

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Education

The Ohio State University, Main Campus is a public research university located in Columbus, Ohio. It offers a comprehensive education with a wide array of undergraduate, graduate, and professional programs. The university is engaged in numerous research initiatives and partnerships, providing opportunities for students, faculty, and industry partners to collaborate. Ohio State promotes a vibrant student life with various academic, recreational, and wellness services to support student needs. It also emphasizes community involvement and leadership development, fostering an inclusive environment on its multiple campuses across Ohio.

- employees

Founded 1870

📚 Education

📋 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