Job Title: IRB Manager

Work Location: Peoria County, Illinois

Summary:

The IRB Manager oversees the Human Subject Protection Program (HSPP) for clinical research, ensuring compliance with all relevant regulations, laws, and ethical standards. This leadership role coordinates with external Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs), while maintaining local oversight and supporting a diverse research portfolio. The position requires expertise in research compliance, regulatory affairs, and team management, and plays a key role in shaping policy, governance, and educational programming for human subject research.

Responsibilities:

• Lead the Human Subject Protection Program, ensuring compliance with federal, state, and local regulations for human subject research.
• Coordinate with external IRBs and IBCs, maintaining local oversight and supporting research activities across clinical, academic, and investigator-initiated studies.
• Develop and implement policies, governance structures, and educational programs to promote ethical research practices and regulatory compliance.
• Oversee IRB reliance agreements, event reporting, compliance monitoring, and risk-based oversight models.
• Serve as a liaison and trusted advisor to investigators, research staff, and leadership on human subject protection matters.
• Lead, mentor, and manage a team of research compliance professionals, fostering continuous improvement and professional development.
• Collaborate with research administration, compliance, legal, privacy, and clinical leaders to support enterprise governance and research oversight.
• Develop scalable processes, metrics, and strategies for continuous improvement in research compliance and participant protection.

Qualifications:

• Bachelor’s degree in Biological/Life Sciences or a related field required; Master’s degree preferred.
• Minimum 5 years of direct experience in clinical research or research compliance, with at least 2 years in a supervisory or management role; 10 years of experience and 5 years in a formal leadership role preferred.
• Experience working with external IRBs as a relying institution and knowledge of IRB processes for both minimal risk and complex biomedical clinical trials.
• Familiarity with regulations governing human subject protection (e.g., 45 CFR 46, 21 CFR 50, 21 CFR 56, HIPAA).
• Experience in monitoring/audits, investigations, and corrective action planning related to research compliance.
• Certified IRB Professional (CIP) or Certified in Healthcare Research Compliance (CHRC) required (or must obtain within 1 year of hire).
• Excellent interpersonal, written, and verbal communication skills; strong analytical, organizational, and project management abilities.
• Proficiency with research compliance software, databases, and MS Office Suite; familiarity with Epic and research functionality preferred.
• Experience in policy development, research ethics, industry clinical trials, academic partnerships, research-related contracts, and development of training/educational content preferred.
• Ability to train and mentor staff and investigators, and provide education to small and large groups.
• General understanding of medical/clinical terminology and the operational, logistical, and administrative requirements of clinical research studies.

Published Category: Clinical Operations & Development