Manager Human Subject Protection Program

Iconma Portal•Peoria, IL

About The Position

The Manager Human Subject Protection Program (HSPP) Clinical Research provides operational, regulatory, administrative, and educational leadership for the institution’s human research protection program. The role promotes compliance with applicable regulations, laws, ethical principles, professional standards, and organizational policies across a growing, system-wide research enterprise operating within a single Federalwide Assurance (FWA) environment. The manager coordinates with external Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs), including oversight of IRB reliance arrangements, while maintaining local institutional oversight and accountability. The position serves as a key liaison between the health system and external entities and advises investigators and leadership on human subject protections, research compliance, and regulatory requirements. The role partners with Research Administration Leadership, Compliance, Legal, Privacy, clinical leaders, and other stakeholders; supports enterprise governance through the Research Oversight Council (ROC); and leads and mentors Research Compliance Analysts and other research compliance professionals. The manager develops scalable processes, metrics, education, policy, and risk-based oversight approaches, and advances continuous improvement as the research enterprise expands.

Requirements

Bachelor’s degree in a relevant field, such as Biological/Life Sciences or another related field.
At least 5 years of direct experience in clinical research or research compliance.
At least 2 years in a supervisory or management role.
Experience working with external IRBs as a relying institution.
Knowledge of the IRB process for both minimal-risk research and complex biomedical clinical trials.
Familiarity with human subject protection regulations, including 45 CFR 46, 21 CFR 50, 21 CFR 56, and HIPAA.
Experience conducting monitoring or audits, investigations, and corrective action planning related to research compliance.
Active Certified IRB Professional (CIP) or Certified in Healthcare Research Compliance (CHRC) certification, or ability to obtain one within 1 year of hire if not active.
Excellent interpersonal and communication skills, including the ability to clearly explain complex regulatory requirements to researchers and staff.
Strong analytical, problem-solving, and decision-making skills, with attention to detail.
Strong organizational and project management skills, including the ability to manage multiple tasks and priorities.
Ability to work collaboratively with researchers, clinical staff, legal counsel, regulatory agencies, and other diverse stakeholders.
Proficiency with Microsoft Office software, including Word, Excel, and PowerPoint.
Knowledge of human subject protection regulations and ethical research guidelines.
Proficiency with research compliance software and databases.
Basic knowledge of the regulatory, operational, logistical, and administrative requirements of clinical research studies.
General understanding of medical and clinical terminology.
Proactive, solution-oriented approach to managing compliance, with an emphasis on communication and collaboration.

Nice To Haves

Master’s degree in Biological/Life Sciences or another closely related field.
At least 5 years in a formal leadership role.
At least 10 years of direct experience in research compliance, research administration, and/or human subject protection.
Familiarity with Epic and its research functionality.
Experience conducting human subjects research.
Experience with post-approval monitoring.
Experience in project management, policy development, or research ethics.
Experience in the industry clinical trial space.
Experience working with academic or university partners.
Experience with research-related contracts, such as material transfer agreements, data sharing and use agreements, and clinical trial agreements.
Experience developing training or educational program content.
Experience training or mentoring staff and investigators.

Responsibilities

Provide operational and regulatory leadership for the Human Subject Protection Program.
Oversee IRB reliance, local oversight, event reporting, and compliance monitoring.
Coordinate with external IRBs and Institutional Biosafety Committees while maintaining institutional oversight of research activities.
Serve as a key liaison between the health system and external review entities.
Ensure research activities comply with federal, state, and local regulations and organizational policies.
Partner with Research Administration Leadership, Compliance, Legal, Privacy, clinical leaders, and other stakeholders.
Lead and mentor a team of Research Compliance Analysts and other research compliance professionals.
Support enterprise governance through the Research Oversight Council (ROC).
Develop scalable processes, metrics, and continuous improvement strategies.
Advise investigators and leadership on human subject protections and research compliance.
Develop policy, governance, education, and risk-based oversight models.
Conduct or oversee monitoring, audits, investigations, and corrective action planning related to research compliance.