Research Reliance Director

University Of Rochester Research Position

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.

Job Location : Remote Work - New York, Albany, New York, United States of America, 12224

Opening : Regular

Time Type : Full time

Scheduled Weekly Hours : 40

Department : 100045 Office for Human Subject Prot

Work Shift : UR - Day (United States of America)

Range : UR URG 115

Compensation Range : $96,860.00 - $145,290.00

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries / hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities

General Purpose Directs all aspects of the Office for Human Subject Protection (OHSP) research reliance program, which requires oversight and negotiation of reliance agreements, to ensure research conducted at multiple sites comply with ethical and regulatory standards by coordinating the review process with external IRBs and maintaining accurate records of all related activities. Requires considerable expertise with federal regulations / guidance and University policies and procedures relating to the conduct of human subject research, regarding reliance and in general, as this position provides back up to the RSRB Director. Directly contributes to the advancement of the University of Rochester as a world-class research enterprise by : 1) ensuring an effective compliance function; 2) promoting the program, its services and solutions to the University research community and 3) establishing, managing and leveraging relationships through a national presence.

Essential Functions

• Direct the University's IRB Reliance program. Supervise IRB Reliance Specialists to ensure efficient and effective processing of protocols, which includes the formulation of acceptable solutions to resolve issues that affect the research subject's rights and welfare and ensures compliance with Institutional requirements for reliance. Ensures initial training and continued education of assigned staff.
• Provide support and backup to the RSRB Director under the direction of the AVP of OHSP. This position will work in tandem with the RSRB Director to fulfill and exceed government mandates to consistently ensure a regulatory compliant program and serves as an advisor to senior leadership and the review boards on human subject matters.
• Negotiate reliance agreements for multi-site research with external stakeholders, which includes compliance with institutional policies and federal regulations, terms of review, fee structures, and data-sharing protocols.
• Oversee the initial review and monitor the ongoing approval of research protocols submitted for reliance to ensure compliance with institutional policies and federal regulations and data-sharing protocols, which includes coordination with investigators and external stakeholders.
• Advise components of the University of Rochester's Human Research Protection Program, including departments, faculty investigators, board members, and other office personnel, in reliance and the resolution of critical issues related to compliance with human subject research regulation and institutional policy to ensure adequate and appropriate reviews of research.
• Assist in the University's HRPP accreditation for continued re-accreditation.
• Serve as a University liaison and representative with federal agencies, and external Institutional Review Boards and HRPPs.
• Maintain knowledge of contemporary trends in the field by self-study and attendance and participation in continuing education activities.
• Other duties as assigned

Minimum Education & Experience

Knowledge, Skills & Abilities

Licenses and Certifications

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.