Provides executive leadership, strategic direction and both internal and external interpersonal capital in directing all the Research Subject Review Board (RSRB) policies and guidance related to the review of all University biomedical, social and behavioral research involving human subjects conducted by any faculty member, employee or student. 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.
Under general direction and with considerable latitude for the exercise of independent judgment and initiative:
- Provides executive direction and oversight to all University research subject review boards as well as regulatory review functions.
- Develop, implement and refine the policies and procedures of the Research Subjects Review Boards (RSRB) to meet relevant local, state and federal regulatory requirements and will foster the expertise, efficiency and innovation within the human subjects review programs and services. Oversee the development, implementation and revision to training programs for the University¿s scientific research community (faculty, staff, and students).
- Serves as advisor to the Director of the Office of Human Subject Protection and to the review boards on human subject matters, bio-safety, and animal research; contributes to research panels on financial conflicts of interests, ethics and compliance.
- Develop, oversee and continuously monitor and improve the audit and risk analysis functions to ensure and maintain the University¿s voluntary and critical accreditation through the Council for Certification of Institutional Review Board Professionals. Develop and implement best practices observed and trended at national levels.
- Responsible for fulfilling and exceeding government mandates to consistently ensure a regulatory-compliant program to enhance the creative and scientific endeavors of the University, and to protect the rights and welfare of human participants in scientific and clinical research.
- Represents the University of Rochester and the Research Subject Review program to professional organizations, government agencies, and internal and external compliance entities. Applies knowledge of and interpretation of governmental regulations to influence decisions of federal agencies such as, but not limited to, the Food and Drug Administration, the National Institutes of Health, the Department of Health and Human Services, and other public and private organizations.
- Serves as primary advocate and role model for the University¿s research endeavors, in service orientation, communication, results and deliverables.
- Provides appropriate responses for public relations personnel for media inquiries; represents the department serving as University liaison with local, state and national hospitals, agencies and other universities on human subject issues.
- Recruits, selects and supervises other professional staff members; oversees the orientation, development and evaluation of employee performance, promotions, salary changes and related personnel changes for the RSRB.
- Oversees administration of the research compliance committees and review boards.
- Performs other related duties as required.
What are the right qualifications?
- Critical Thinking
- Customer Service
- Priority Setting
- Institutional Review Board
- IRB Certified
- Human Subject Research
Master's degree in Social Sciences or Biomedical related Sciences and 8 years of related experience in clinical and biological research; or an equivalent combination of education and experience. Doctorate preferred.
Interested in Applying…Go to the University of Rochester Website…
UR Job ID: 210566