OverviewPOSITION SUMMARY: The Director, Research Compliance & Human Subject Protection provides enterprise-level leadership and oversight of OSF HealthCare's Human Subjects Protection Program (HSPP) under the institution's Federal wide Assurance (FWA), ensuring all human subject research conducted across the health system meets applicable federal, state, and local regulations, ethical standards, and institutional governance requirements. Operating within a reliance model that utilizes external Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs), this role maintains robust local oversight, regulatory risk management, and post-approval monitoring programs to safeguard research participants and protect the organization. The Director serves as the institutional authority for research compliance and human subject protection across all OSF ministries, providing system-wide oversight of regulatory risk affecting investigators, research personnel, and research activities throughout the enterprise.
QualificationsREQUIRED QUALIFICATIONS:
Education:
- Bachelor's degree in biological/life sciences, public health, healthcare administration, regulatory science, or related field.
Experience:
- 7 years of progressive experience in research compliance, human subject protection, or research administration within a healthcare or academic medical center environment.
- 3 years in formal leadership role.
- Demonstrated experience working within an external IRB reliance model.
Licensure/ Certification:
- Certified IRB Professional (CIP) certification OR Certified in Healthcare Research Compliance (CHRC) (if not active, much obtain within 1 year of hire into the role).
Other Skills/ Knowledge:
- Comprehensive knowledge of federal regulations governing human subject protection (45 CFR 46, 21 CFR 50/56), HIPAA, and ICH-GCP. Strong business acumen with ability to develop compliance metrics, KPIs, dashboards, and executive-level reporting.
- Demonstrated project management capability in complex, cross-functional environments.
- Excellent written and verbal communication skills with the ability to translate regulatory requirements into operationally feasible institutional processes.
- Ability to exercise independent judgment in high-risk and high-pressure situations.
- Proficiency with research compliance systems and standard office software applications.
PREFERRED QUALIFICATIONS: Education:
- Master's degree in biological/life sciences or other closely related field.
Experience:
- 5 years in formal leadership role.
- 10 years of experience in research compliance, human subject protection, or research administration.
- Experience supporting FDA-regulated, oncology, or early-phase clinical trials.
- Experience developing and scaling post-approval monitoring and institutional QA programs.
- Experience presenting to executive committees or governing councils.
- Project Management Professional (PMP) certification preferred. Familiarity with Epic research functionality, iRIS/Cayuse, and other research compliance systems.
Other Skills/ Knowledge:
- Basic knowledge and understanding of the regulatory, operational, logistical, and administrative requirements of clinical research studies. General understanding of medical/clinical terminology. Demonstrated ability to develop training materials and train individuals and provide education to small and large groups.
