Administrative Skills, Animal Research, Code of Federal Regulations, FDA Requirements, Federal Government, Federal Laws and Regulations, Health Science, Healthcare, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Leadership, Maintain Compliance, Operational Strategy, Operations Management, Quality Management, Regulations, Research Administration, Research Skills, Standard Operating Procedures (SOP), Writing Skills
GENERAL SUMMARY:
- Research Compliance is centralized to Research Administration at the main campus.
- The Senior Coordinator-Research Compliance has administrative responsibility for our institutional research compliance committee(s).
- The position is responsible for ensuring that Henry Ford Health research activities comply with federal, state, local, regulatory agencies, and Henry Ford Health regulations and policies for the conduct of research involving animal and human studies.
- The position ensures the efficient committee operations that include writing meeting agendas, recording minutes, writing correspondence, maintaining quality data in the compliance database, and monitoring approval period lapses.
- This individual generates information that is reported out to departments, the committee(s), and Henry Ford Medical Group (HFMG) leadership.
- The position is knowledgeable of federal agency, state, local, and Henry Ford Health guidelines, and ensures that this information is disseminated out to the research community.
- Also responsible for ensuring that the appropriate training occurs for researchers and committee members as required by federal regulations.
- Develops and/or implements education modules, standard operating procedures, and policies for the research community.
EDUCATION/EXPERIENCE REQUIRED:
- Bachelor's degree in compliance, health sciences, health related field, or business.
- Master's Degree preferred.
- Preferred Qualifications:
- In depth knowledge of: OHRP / Common Rule (45 CFR 46); FDA regulations (21 CFR 50, 56); HRPP / AAHRPP standards
- Direct IRB administration experience
- Multi-committee exposure (highly valuable at HFH) to IRB + IACUC + IBC/Biosafety familiarity & Understanding of cross-committee coordination and dependencies.
- Systems experience of IRB platforms (IRBNet, eIRB systems, etc)
- Preferred Credentials: CIP (Certified IRB Professional) , CHRC (Certified in Healthcare Research Compliance) or working toward it
- Comfortable working in High-volume, complex academic healthcare system with a mix of: Investigator-initiated research, Industry-sponsored trials, and Increasing cross-institutional work (e.g., MSU integration, reliance models)
Additional Information
- Organization: Henry Ford Medical Group
- Department: Administration-Research
- Shift: Day Job
- Union Code: Not Applicable