Assoc. Vice President for Human Subject Protection

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

• Reviewing protocols submitted for approval by IRB for completeness and compliance with the Office of Human Subject Protections (OHSP) regulations, other federal regulations, state and local laws, and IRB Policy and Procedures.
• Providing oversight and support for the Research Subject Review Boards (RSRBs) including evaluation of submissions for appropriate assignment of review category under Federal guidelines (e.g., Exempt, Expedited, Full Review).
• Providing education/outreach/training for the research community, as needed, regarding the overall OHSP, including, but not limited to: (a) determining when IRB review is necessary; (b) identifying appropriate categories of review; (c) protocol submission process and procedures including use of, and technical support for, the electronic submission system (Click IRB); and (d) the institutional education/training program.
• Building relationships with internal stakeholders (including consulting with researchers) and liaising with the Office of Research Integrity, internal audit representatives, and various stakeholders to build a culture of compliance.
• Assisting researchers with compliance reporting requirements in accordance with Federal regulations. Overseeing the quality assurance monitoring of the OHSP, including investigation of matters of noncompliance; and ensuring implementation of corrective action, as needed, in accordance with the policies and procedures of OHSP and the RSRB.
• Representing OHSP and the University of Rochester as a liaison with regulatory agencies, accrediting bodies (as applicable), and funding agencies. Ensuring HIPAA compliance.

Other duties as assigned

QUALIFICATIONS

Required:

• A bachelor’s degree is required; a master’s degree in a field that entails working with human subjects preferred
• At least 10 years of directly relevant experience with human research compliance, regulatory compliance, and/or IRB administration, or equivalent combination of education and experience.
• Experience with human research compliance, regulatory compliance, and/or IRB administration.
• Strong interpersonal skills and ability to diplomatically navigate complex and sensitive situations. Including experience developing and managing relationships with a wide variety of internal and external stakeholders and a demonstrated ability to collaborate effectively with diverse faculty working in a range of research disciplines.
• Demonstrated understanding and detailed working knowledge of federal regulations and agency guidelines for conducting research and the protection of human subjects.
• The ability to promote and implement activities to ensure compliance with federal and state regulations governing research.
• Demonstrated commitment to advancing health equity through research. 
• Superb verbal and written communication skills, including the ability to constructively resolve conflicts and problem-solve.
• Ability to synthesize information from multiple sources to produce succinct, detail-oriented, and accurate documents, policies, reports, and announcements.
• Ability to exercise sound and consistent judgment within a defined process.
• Advanced competence utilizing MS Office suite, computerized databases, and other technological products that facilitate effective management.
• Fluency in cloud- or remote-based computer environments and video conferences.

Preferred:

• IRB Professional Designation

EOE Minorities / Females / Protected Veterans / Disabled:

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion 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 status protected by law.  This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.