Research Reliance Director

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 (Full Address):

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

Opening:

Worker Subtype:

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

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

• Master's degree in biomedical or social sciences (e.g., MPH, MS) Required
• 8 years of related research experience or an equivalent combination of education and experience required.
• Preferred experience in human subject research and reliance.

Knowledge, Skills & Abilities

• Possesses excellent interpersonal, communication, and leadership to manage a dynamic staff and collaborates effectively with team members, researchers, external agency representatives, and senior leadership. 
• Demonstrates critical thinking and flexibility in decision making in the application of policies and regulations in very complex situations. 
• 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 and the review boards served by the office. 

Licenses and Certifications

• Certified IRB Professional, or willingness to become certified within 6 months of eligibility ​

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