Regulatory Compliance Officer – Clinical Trials

Role Overview

• 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 (academic, federal, industry) to ensure compliance
• Interfaces with various internal and external entities to coordinate and effectively compile all appropriate data relevant to the conduct of a CTO trial
• Develops IRB submission packets for protocols, including writing of abstract, submission of standard forms and drafting of informed consent forms
• Provides and maintains tracking system to assess progress of a protocol's review; maintains regulatory essential files on submitted and approved studies
• Reviews all protocol revisions and amendments; amends consent forms if needed and follows established guidelines to determine if amendments require IRB review
• Distributes all amendments and IRB approved informed consent forms to relevant university protocol holders
• Acts as main point of contact for the dissemination of all approved study material and works collaboratively with various internal and external departments to ensure relevant updates are communicated effectively and timely
• Attends meetings; serves as principal contact from CTO to regulatory agencies including FDA and IRBs
• Continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements
• Provides regulatory updates and guidance to investigators and research staff of new or changed regulations; participates in audits and site visits

Requirements

• Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required
• 1 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

• Medical, dental and vision insurance
• Tuition assistance for employees and their dependents
• State or alternative retirement options with competitive employer contributions