Director, RSRB

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

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ESSENTIAL FUNCTIONS

• Directs and manages the University’s Institutional Review Board operations ensuring compliance with federal regulations and institutional policies, including the review and approval process for research protocols ensuring timely, efficient, and compliant processing of submissions.
• Develops, implements, and continuously improves institutional policies, processes, and procedures governing human subject research to meet and exceed federal, state, and local regulatory requirements, ensuring a robust and compliant human subjects protection program that both enhances the creative and scientific endeavors of University researchers and protects the rights and welfare of human participants in scientific and clinical research.
• Directs and manages RSRB professional staff responsible for all areas of compliance oversight, with authority for hiring, training, performance management, and succession planning. Establishes structures and expectations to ensure a sustainable and high-performing administrative workforce. Oversees the maintenance of auditable records and compliance systems. Directs staff in ensuring accuracy, accessibility, and readiness for internal and external audits. Ensures the University has the policies and systems in place to withstand federal scrutiny.
• Provides executive direction and oversight to all University research subject review board committees as well as regulatory review functions. Oversees and manages the RSRB committees, including faculty board member recruitment, training, and ongoing education; ensures proper and consistent review of research protocols; maintains accurate and complete records of RSRB activities and decisions.
• Represents the University externally through interactions with federal oversight agencies (OHRP, NIH, NSF, FDA, etc.) and active participation in national compliance forums. Anticipates and interprets evolving policies, regulations, and trends, and proactively advises senior leadership on compliance risks and opportunities. Represents the University at the national level by serving as a liaison with federal, state, and local government agencies, as well as peer institutions. Builds and sustains strategic partnerships across the University and with external stakeholders. Serves as a University lead representative on committees addressing human subject research compliance as well as a trusted advisor to University senior leadership.
• Ensures and maintains the University’s voluntary and critical accreditation through the Association for the Accreditation of Human Research Protection Programs by developing, implementing, and sustaining best practices.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Master’s Degree in a relevant field required
• 8 years of experience, including experience in a supervisory capacity
• or equivalent combination of education and experience required

KNOWLEDGE, SKILLS AND ABILITIES

• Experience in IRB operations required
• Extensive knowledge of federal regulations governing human subject research required
• Strong leadership, organization, and communication skills required
• Ability to interpret regulations and policies and make decisions with high impact on the University research community required
• Able to manage effectively in a remote environment that requires constant evaluation and shifting of priorities to respond to the needs of the University research community required

LICENSES AND CERTIFICATIONS

• Certified IRB Professional (CIP) or ability to obtain within 180 days of hire required

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.