Stephanie Madrigal
Director, Clinical Research Administration @OSF HealthCare
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WORK HISTORY
Director, Clinical Research Administration @OSF HealthCare
Lead enterprise research administration strategy and infrastructure for a large integrated healthcare system supporting a rapidly expanding clinical research enterprise. Responsibilities include oversight of institutional research governance, human subjects protection, research compliance, financial infrastructure, and system-wide research program development.• Enterprise leadership for Human Subjects Protection Program and research compliance• Chair the executive Research Oversight Council guiding research strategy and governance• Lead institutional oversight under a single Federalwide Assurance with external IRB reliance• Develop system-wide research governance frameworks and operational infrastructureSelected Achievements• Architected and led enterprise restructuring of the Human Subjects Protection Program, implementing a single-IRB institutional model with IRB reliance capability and unified FWA oversight supporting scalable research growth.• Built the health system’s research administration infrastructure from the ground up, establishing governance frameworks, policies, and operational processes supporting a multi-hospital research enterprise.• Established and chair the executive Research Oversight Council, providing enterprise governance and strategic leadership for research conducted across the organization.• Developed enterprise research financial compliance and billing oversight infrastructure, strengthening regulatory compliance and financial stewardship for clinical research activities.• Helped position the organization for expansion as a destination health system for clinical research, building the governance, compliance, and operational infrastructure required to support a scalable research enterprise.
EDUCATION
Bradley University
Master of Business Administration (M.B.A.), Executive Leadership
Bradley University
Bachelor of Science Degree
ABOUT STEPHANIE MADRIGAL
Mission-driven healthcare research executive advancing enterprise clinical research programs through governance, infrastructure, and human subjects protection.I bring 20+ years of experience leading and building enterprise clinical research programs within health systems, with a focus on developing the governance, infrastructure, and operational frameworks necessary to support safe, compliant, and scalable research enterprises.Experience includes:• 10+ years leading clinical research operations• 10+ years in research administration leadership• Building enterprise research administration programs from the ground up• 4 years direct IRB operational experience• 22+ years serving as an IRB board member• Chair of an executive Research Oversight CouncilI specialize in enterprise research governance, human subjects protection, and the development of operational and financial infrastructure that enables sustainable research growth across complex health systems.I am passionate about positioning health systems as destination centers for clinical research, expanding access to innovation while maintaining the highest standards of participant protection, regulatory compliance, and operational excellence.Core Expertise• Enterprise Research Administration• Human Subjects Protection Programs (HSPP)• Research Governance & Institutional Oversight• Clinical Research Operations• Research Financial Compliance & Billing• IRB Governance & Reliance Models
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