Manager Human Subject Protection Program

Our client a Integrated Health System company is looking for a Manager Human Subject Protection Program for their Peoria IL location.

Responsibilities:

• The Manager Human Subject Protection Program (HSPP) Clinical Research 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 client 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 institutions 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).
• Help build the future of ethical compliant high-impact research.
• Client is seeking a Manager Human Subject Protection Program (HSPP) to play a pivotal leadership role in a rapidly growing system-wide research enterprise. This role is ideal for a seasoned clinical research professional who thrives at the intersection of regulatory compliance operational oversight investigator partnership and enterprise risk management.
• As Manager HSPP you will lead and evolve client Human Research Protection Program within a single FWA environment supporting a diverse portfolio of clinical academic and investigator-initiated research -- largely in reliance with external IRB -- while maintaining strong institutional oversight and accountability.
• Client research enterprise is expanding in scale complexity and strategic importance including Cancer Institute growth and Destination Client priorities
• This role directly protects research participants investigators and the organization
• You will help shape policy governance education and risk-based oversight models for a large health system
• Your work enables research to move faster without compromising compliance or safety
• 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
• A systems thinker who understands both the letter and spirit of human subjects regulations
• Comfortable navigating complex organizations competing priorities and change
• A collaborative leader who balances service to investigators with firm regulatory accountability
• Experienced in external IRB reliance models and institutional oversight responsibilities
• Motivated by mission integrity and building something that lasts

• Bachelors 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 -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.).
• Masters 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.

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities