Regulatory Specialist II, Research Subjects Review Board

GENERAL PURPOSE:

Manages the activities and processes associated with research protocols as they relate to risk assessment, local, state and federal guidelines, ethical principles and the compliance with regulations protecting the rights and welfare of human research subjects and their participation in research activities. Serves as advisor to investigators on the resolution of critical issues related to human subject protocols and protection. Manages the Research Subject Review Board to ensure timely, efficient and appropriate review and monitoring of research. Manages the initial and the continued regulatory compliance for an assigned portfolio of research and clinical departments to ensure efficient and timely processing of scientific protocols.

Manages the UR Reliance process for applicable studies including facilitating reliance agreements and institutional requirements between the UR HRPP and outside/external IRBs when the UR RSRB is the Reviewing IRB. Key liaison between the UR RSRB, UR Principal Investigators (PIs) and research teams, external research sites, and other external organizations and IRBs as it relates to RSRB reliance issues.

This position is 100% remote with the possibility for some in-person meetings. Note that there specific UR requirements for employees who work out of state.

JOB DUTIES AND RESPONSIBILITIES:

• Conducts specialized risk, compliance and protocol analysis of research applications in order to determine the nature and level of risk and therefore, which level of Research Subject Review the protocol shall be subject to (e.g. exempt (little or no risk), expedited (minimal risk) and/or convened board review (greater than minimal risk). Manages the research review process throughout the life cycle of a research proposal. Serves as consultant to investigators, making recommendations for revisions to protocol and making solution-oriented recommendations to the protocol to revise, minimize, or mitigate risk associated with the protocol and its use of human subjects.

• Reviews Reliance Agreements to ensure Institutional requirements are met, and communicates with internal and external entities to facilitate and execute these agreements. When the UR is the Reviewing IRB for multi-site research, review, track and manage applications, including the determination for eligibility. Review applications from Relying (non-UR sites) to ensure institutional information is provided and reviewed consistent with board requirements. Liaise with Relying IRBs, as necessary.

• Conducts continued monitoring and management of research applications after the approval process by counseling investigators in regard to changes in study parameters, assisting in the development and implementation of solutions to resolve issues that affect research subject’s rights, welfare and to ensure compliance with federal guidelines and University policies and procedures. Advises and communicates with investigators, research coordinators, sponsors, monitors and others involved in the conduct of research for continued regulatory compliance.

• Manages the online submission process to ensure effective, collaborative and iterative analysis of all research protocols to ensure compliance with federal regulations and University policy.

• Manages the review of agenda items at board meetings, then analyzes the results and Board discussions to prepare stipulations for approval, which must be addressed by the investigator before the proposal can be approved by the Board. Serves as primary consultant to the Board and to the investigators, making recommendations for revisions to protocol and making solution-oriented recommendations to the protocol to revise, minimize, or mitigate risk associated with the protocol and its use of human subjects.

• Collaborates with other University entities, such as Office of Research Project Administration, University IT, and the Office of Clinical Research for the purpose of facilitating the financial and administrative aspects of human subject research. May represent and participate in University Committees on behalf of the Office for Human Subject Protection.

• Attends educational seminars and participates in continuing education activities to maintain knowledge of contemporary trends in the field and knowledge in University policies, state and federal regulations which govern research with human subjects, as well as, research/medical ethics for the purpose of appropriate and accurate decision making in the review of the research conducted at the University; Obtain/maintains certification requirements, as applicable.

Other duties as assigned

QUALIFICATIONS:

• Bachelor’s Degree required

• Master’s Degree preferred

• 3-5 years of human subject research experience required

• or equivalent combination of education and experience

• Possesses excellent interpersonal and communication skills and the ability to work effectively with team members and researchers required.

• Demonstrates critical thinking and flexibility in decision making in the application of policies and regulations required.

• Able to work effectively in an environment that requires constant evaluation and shifting of priorities to respond to the needs of the University research community required.

• Institutional Review Board (IRB) Professional preferred

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.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Location: Central Administration
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 055 Office for Human Subject Prot
Schedule: 8 AM-5 PM