You’ll need
Certifications
✓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).
Project Management Professional (PMP) certification preferred.
Education
✓Bachelor’s degree in biological/life sciences, public health, healthcare administration, regulatory science, or related field.
Master’s degree in biological/life sciences or other closely related field. preferred
Qualifications
✓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.
✓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.
✓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.
✓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.
Familiarity with Epic research functionality, iRIS/Cayuse, and other research compliance systems. preferred
Benefits
Benefits package (see posting)
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Employer-posted ranges only
About the role
Actual pay will be determined by experience, skills and internal equity. This is a Salaried position.