The Manager, Office of Research Integrity oversees the daily operations of the Office of Research Integrity, ensuring alignment with institutional goals and compliance with internal and external regulations. This role collaborates closely with Research Administration, Legal Services, and Compliance to support research integrity across the organization. The manager supervises staff and functions related to Research Integrity, Institutional Review Board, Financial Conflict of Interest, Food and Drug Administration, and other regulatory and compliance matters. They lead and mentor a multidisciplinary team focused on compliance, education, and process improvement, while designing and delivering educational programs for investigators and study teams. The manager also provides consultative support on study design and regulatory navigation, streamlines IRB processes and onboarding, and oversees investigations of research misconduct. Additionally, they act as the primary liaison with federal oversight agencies and report to senior leadership on integrity metrics and improvement opportunities. Cross-functional integration across research operations is a key aspect of this role.
Responsibilities:
· Direct daily operations of the ORI, ensuring alignment with institutional goals and strategic priorities.
· Collaborate with investigators to embed scientific rigor into health services research and implementation science projects.
· Streamline IRB processes, credentialing, and onboarding for clinical scientists using data-informed approaches.
· Promote ethical and transparent use of AI in research, developing guidelines and educating teams on risks and opportunities.
· Facilitate cross-functional integration across research operations, compliance, analytics, finance, and clinical trials administration.
· Oversee intake and investigation of research misconduct.
· Act as primary liaison with federal oversight agencies and report to senior leadership on integrity metrics and improvement opportunities.
Other information:
Technical Expertise
· Deep understanding of federal research integrity regulations (e.g., 42 CFR Part 93).
· Familiarity with AI governance and ethical use in clinical research.
· Competency in process improvement methodologies.
· Experience in clinical trials administration, billing, and conduct.
· Knowledge of research finance, accounting, and biostatistics.
Education and Experience
1. Education: Bachelor's degree required; master's degree in a scientific, legal, or regulatory field preferred.
2. Certification: Certification in research compliance (Certified IRB Professional, Certified in Healthcare Research Compliance, Certified Research Administrator) preferred.
3. Years of relevant experience: Minimum 3 years of experience in research compliance, administration, or health services research
4. Years of supervisory experience: Minimum 2 years of supervisory experience.
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