Regulatory Compliance Officer – Clinical Trials

• Collaborate with investigators during study development to facilitate and confirm appropriate regulatory safeguards
• Conduct detailed reviews of assigned protocols and informed consent forms before IRB review
• Ensure timely submission of protocol documents to appropriate agencies
• Communicate with academic, federal, and industry sponsors of CTO research projects to ensure compliance
• Coordinate with internal and external entities and compile data relevant to CTO trials
• Develop IRB submission packets, including abstracts, standard forms, and informed consent forms
• Maintain protocol review tracking systems and regulatory essential files
• Review protocol revisions and amendments and determine whether amendments require IRB review
• Amend consent forms when needed
• Distribute amendments and IRB-approved informed consent forms to relevant university protocol holders
• Serve as the main point of contact for disseminating approved study materials
• Collaborate with internal and external departments to communicate updates
• Attend meetings and serve as the CTO’s principal contact with regulatory agencies, including the FDA and IRBs
• Monitor federal and sponsor rules, regulations, and processes for new or changed requirements
• Provide regulatory updates and guidance to investigators and research staff
• Participate in audits and site visits

• 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
• Final candidates subject to successful completion of a background check
• Drug screen or physical may be required during the post-offer process

Demonstrates expertise in regulatory compliance and protocol management within clinical research, including the development of informed consent documents and interaction with regulatory agencies such as the FDA and IRBs.

• Regulatory Compliance
• IRB Submission Development
• Protocol Review and Tracking
• Research Regulations Knowledge
• Informed Consent Document Preparation

• Protocol Review
• Informed Consent Development
• Regulatory Document Preparation
• Data Compilation
• Regulatory Safeguards Implementation
• Amendment Review
• Audit Participation
• Research Project Coordination
• Compliance Monitoring
• Background Check Completion

• Collaboration
• Communication
• Detail Orientation
• Problem Solving
• Interpersonal Skills

• Clinical Trials
• FDA Regulations
• IRB Processes
• Research Guidelines
• Federal Compliance

• Protocol Review Tracking Systems
• Regulatory Essential Files