Assistant Director, Administrative Services
Assistant Director, Administrative ServicesJob Description:
The Institutional Review Boards (IRBs) are a group of scientists and others who review human subjects research at UF under the rules and regulations of the OHRP, FDA, Privacy Rule, and other applicable agencies which safeguard the rights and welfare of human subjects. This position is responsible for facilitating the use of the IRBs and administering the University of Florida’s compliance with these rules and regulations. This position works with multiple IRB’s: one at the Health Science Center (IRB-01), one for non-Health Center research (IRB-02), one at the University of Florida Health Science Center, Jacksonville (IRB-03), Western IRB (WIRB) in Puyallup, Washington, any other new IRBs that may be created under the University’s Federal-Wide Assurance, as well as facilitating sIRB reliance agreements with other universities. This position is primarily responsible for supervising the staff supporting IRB-01 and IRB-02, but also has responsibility to assure consistency among the four IRBs with respect to the quality of their reviews. IRB-03 has its own administrative support staff supervised by the the local DSP Assistant Director for IRB-03. WIRB is a large commercial enterprise and their services are paid by the sponsor, either directly or by reimbursing UF for their services. Responsibilities for this position include the following:
- Regulatory compliance: Ensures fully documented compliance with all IRB directives, applicable rules and regulations. This includes obtaining, disseminating, and maintaining all applicable federal, state, and institutional rules and regulations.
- Works with the committee Chairs to develop and maintain IRB procedures in compliance with all such guidelines. Prepares material for the Federal Wide Assurance document and documents that are required by OHRP and the FDA for review and forwarding by the President or Vice President for Research. Serves as the initial contact for Federal Auditors and informs the appropriate university officials of such visitors or planned visits.
- Ensures compliance with the sunshine and open records laws while protecting the confidentiality of research proprietary information and patient Personal Health Information (PHI). Works with IRB Chairs, Director of Research Operations and Services, General Counsel and other compliance offices regarding regulatory issues, IRB policy, noncompliance and subject complaints.
- Insures the Director of Research Operations and Services and the Vice President for Research are informed of regulatory risks, issues, and noncompliance and implements institutional corrective action if required.
- Is advised by General Counsel and the Director of Research Operations and Services on issues of Policy.
- Develops, plans, and implements programs to inform investigators and IRB members of the required procedures and formats for research proposals that involve human subjects.
- Develops and updates informational resources and continuing education offerings for Board members, staff, and researchers.
- Works with new faculty to make them aware of the IRB and its role, and to offer assistance.
- Works with other research compliance offices such as the Division of Sponsored Programs, the VA, and others to address human research related issues.
- Works with General Counsel and Director of Research Operations and Services to address international research, entering into IRB Authorization Agreements with other institutions, and allowing outsiders to access UF or its faculty, staff, or students for non-UF human research.
- Manages IRB administrative office operations. Supervises administrative staff. Provides administrative/operational support for database systems to manage IRB record keeping. Oversees the management of the IRB websites. Prepares and administers operating budget. Develops and maintains internal office policies and procedures. Responsible for records maintenance and retrieval. Assists in the development of business related metrics to insure efficient operation. Responsible for ensuring that IRB records reflect verifiable compliance with all applicable guidelines.
- Assists in the coordination of all four IRB’s so each IRB can function in an effective, efficient manner.
- Analyzes opportunities to improve services and implements enhancements.
Commensurate with education and experience.Minimum Requirements:
Master’s degree in appropriate area of specialization and two years of appropriate experience or a bachelor’s degree in appropriate areas of specialization and four years of experience.Preferred Qualifications:
Employee must have managerial experience in order to be effective in the performance of these job dutiesSpecial Instructions to Applicants:
In order to be considered, you must upload your cover letter, resume and a list of references.
A background check is required for this position.
Application must be submitted by 11:55 p.m. (EDT) of the posting end date.Health Assessment Required: No.