Manager Human Subject Protection Program

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Expected pay for this position is $42.64 - $56.50/hour. Actual pay will be determined by experience, skills and internal equity. This is a Salaried position.

Overview

This position is not eligible for H1B sponsorship.

POSITION SUMMARY:

The Manager Human Subject Protection Program (HSPP) is responsible for overseeing administrative and educational programming that promotes and supports compliance with regulations, laws, ethical principles, and professional standards that govern the responsible and ethical conduct of human subject research and activities throughout the broader research enterprise. Given that OSF relies on external Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs), the Manager will coordinate with these external entities while maintaining local oversight programming of the institution's research activities.

The Manager will be the key liaison between the health system and the external entities, ensuring that all research activities are compliant with federal, state, and local regulations, as well as organizational policies for human subject protection. This role demands expertise in biomedical clinical trials and academic research, research compliance, ethical principles, and the regulatory landscape surrounding human subject research. Strong organizational, communication, and leadership skills are necessary to manage projects and a team of Research Compliance Analysts (RCAs).

Qualifications

REQUIRED QUALIFICATIONS:

Education:

Bachelor's degree in a relevant field (e.g., Biological/Life Sciences or other related field)

Experience:

• 5 years of direct experience in clinical research or research compliance, with at least 2 years in a supervisory or management role.
• Experience working with external IRBs as a relying institution and knowledge of the IRB process for both minimal risk research 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 conducting monitoring/audits, investigations, and corrective action planning related to research compliance.

Licensure/ Certification:

Certified IRB Professional (CIP) certification OR Certified in Healthcare Research Compliance (CHRC) (if not active, must obtain within 1 year of hire into the role)

Other Skills/ Knowledge:

• Excellent interpersonal and communication skills.Strong analytical and problem-solving skills, with the ability to be detail oriented.
• Solid computer skills, including proficiency with Microsoft software.In-depth knowledge of human subject protection regulations and ethical research guidelines. This position will require a proactive, solution-oriented approach to managing compliance, with a strong emphasis on communication and collaboration with both internal and external stakeholders.
• Strong organizational and project management skills, with the ability to manage multiple tasks and priorities.
• Excellent written and verbal communication skills, with the ability to communicate complex regulatory requirements clearly to researchers and staff.
• Strong problem-solving and decision-making skills, particularly in high-pressure situations.
• Ability to work collaboratively with diverse teams, including researchers, clinical staff, legal counsel, and regulatory agencies.
• Proficiency with research compliance software and databases, as well as MS Office Suite (Word, Excel, PowerPoint, etc.).

PREFERRED QUALIFICATIONS:

Education: Master's degree (e.g., Biological/Life Sciences or other closely related field)

Experience:

5 years in formal leadership role.

10 years of direct experience in research compliance, research administration, and/or human subject protection.

Familiarity with Epic and research functionality, Experience conducting human subjects research, Post approval monitoring, project management, policy development, research ethics, experience in industry clinical trial space, experience working with academic/university partners, research-related contracts (e.g. - material transfer agreements, data sharing and use agreements, clinical trial agreements), development of training/educational programmatic content, training/mentorship of staff and investigators.

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.