OSF HealthCare · 1 day ago
Manager Human Subject Protection Program
OSF HealthCare is dedicated to providing a comprehensive total rewards package and is seeking a Manager for the Human Subject Protection Program (HSPP) to lead their growing research enterprise. This role involves overseeing regulatory compliance, operational leadership, and mentorship of research compliance professionals while ensuring ethical conduct in human subject research.
Air TransportationEducationElectronic Health Record (EHR)Health CareMedicalTransportation
Responsibilities
Provide operational and regulatory leadership for the Human Subject Protection Program
Oversee IRB reliance, local oversight, event reporting, and compliance monitoring
Partner closely with Research Administration Leadership, Compliance, Legal, Privacy, and clinical leaders
Lead and mentor a team of research compliance professionals
Support enterprise governance through the Research Oversight Council (ROC)
Develop scalable processes, metrics, and continuous improvement strategies
Serve as a trusted advisor to investigators and leadership on human subjects protections
Qualification
Required
Bachelor's degree in a relevant field (e.g., Biological/Life Sciences or other related field)
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
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)
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
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
Master's degree (e.g., Biological/Life Sciences or other closely related field)
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
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
Benefits
Relocation Assistance is Available
Company
OSF HealthCare
OSF Healthcare is an air transportation company that offers helicopter air-medical transportation services.
Funding
Current Stage
Late StageTotal Funding
$1.5M2025-07-16Grant· $1.5M
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