PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
Research Integrity & Compliance (RIC) is a unit within the USF system vice presidential area, Research & Innovation. The main function of RIC is to ensure compliance with federal and state regulations pertaining to the responsible conduct of research. RIC is responsible for such programs as the Human Research Protection, Animal Safety, Diving Safety, Radiation Safety, Biosafety, Scientific Misconduct, Conflicts of Interest in Research, and HIPAA, among others. The department has 34 employees and an annual budget of nearly $3 million. Clients are USF research faculty, students, and staff, as well as researchers at affiliated institutions.
This position will serve as the primary point of contact and source guidance for single Institutional Review Board (IRB) review and reliance/master agreements. This position will be responsible for reviewing applications to cede review to an external IRB and managing the associated workload, including negotiating and facilitating execution of contracts, creating policy and procedures and educating the research community about the regulatory requirements and USF?s process for ceding review. This position will also be responsible for taking a leadership role in developing policies and procedures related to serving as a reviewing IRB.
Manages and conducts reviews of reliance request applications that are submitted, requesting that USF rely on an external IRB or serve as a single IRB. Serves as an administrative reviewer to complete USF IRB review of external reliance IRB applications. Confirm necessary components related to IRB reliance as part of USF IRB review of reliance requests, including review of local context issues and review of local informed consent templates.
Develops and implements new policies and procedures and revisions to existing institutional policies and procedures, but specifically serves as a key player in developing policies/procedures related to reliance on independent/commercial or other external IRBs. Develops and implements training/educational materials for the research community (e.g. how to submit reliance requests, PI responsibilities in reliance arrangements), as well as training and education for IRB staff on how to review and process protocols covered by an authorization agreement.
Serves as the primary point of contact and source guidance for single IRB review and reliance/master agreements. Advises and provides consultative services to researchers and research staff to facilitate reliance on external IRBs and the use of USF's IRB as the single IRB for a multi-site project.
Negotiates, coordinates and tracks USF IRB review and documentation pertinent to the use of IRB reliance/master agreements for situations when another institution relies on the USF IRB's review and when USF relies on an IRB at another institution.
Performs miscellaneous job duties as assigned by supervisor or associated administration.
This position requires a Bachelor's degree and four years of experience in safety or research compliance; or a Master's degree and two years of experience in safety or research compliance. Progressively responsible experience involving safety or research compliance may be substituted on a year for year basis for required education.
A Master's degree in Research Administration, Health Administration, or Public Administration and five years relevant program experience or business administration experience. Prior experience working with federal regulations and guidelines related to human subjects research. Prior experience with central/single IRB and negotiating reliance agreements desirable. Experience in contract negotiation or management. CIP certification preferred. Knowledge and familiarity with FDA regulations, the Common Rule, OHRP guidance, the Privacy Rule preferred. Experience with electronic compliance systems preferred but not required.
Internal Number: 17478
About University of South Florida Research-Integrity and Compliance
USF Research, Innovation & Economic Development (USFRI) is charged with the central administration and oversight of the USF System research enterprise. USFRI promotes USF research; stimulates economic development; provides services and assistance to facilitate faculty, staff, and student research efforts; ensures compliance with research-related laws, regulations, and policies of federal, state, sponsoring agencies and organizations, and the university; and provides for the protection and promotion of intellectual property generated by USF System employees.
Research Integrity & Compliance (RIC) is a unit within the USF system vice presidential area, Research & Innovation. The main function of RIC is to ensure compliance with federal and state regulations pertaining to the responsible conduct of research. RIC is responsible for such programs as the Human Research Protection, Animal Safety, Diving Safety, Radiation Safety, Biosafety, Scientific Misconduct, Conflicts of Interest in Research, and HIPAA, among others.