Qualifications
REQUIRED 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.
- OSF HealthCare is an Equal Opportunity Employer.
Qualifications
REQUIRED 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.
- OSF HealthCare is an Equal Opportunity Employer.
