Research Compliance Administrator I

at  University of South Florida

Dept Number/Name: 0-7910-000 / Research Integrity &Compliance
College Division: Research-Integrity and Compliance
Salary Plan: Administrative
Job Code/Title: 4716 / Research Compliance Administration

ORGANIZATIONAL SUMMARY:

Research Integrity & Compliance (RIC) is a unit within the USF system vice presidential area, USF 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. RIC has 32 employees and an annual budget of nearly $3 million. Clients are USF research faculty, students, and staff, as well as researchers at affiliated institutions.

POSITION SUMMARY:

Apply and implement federal regulations, IRB guidelines and institutional policies related to the protection of human research participants and research integrity; ensuring conformance with ethical and regulatory standards. Serve as an expert resource to the University’s research community (faculty, staff, students, etc) and serving as the liaison between the research community and the USF IRB to ensure that research conducted by USF and Affiliate investigators and research staff meet all regulatory and institutional policies and procedures to protect human subjects participating in USF research. Provide professional support to one of the Institutional Review Boards.

Provides consultation to faculty, staff, students and affiliate investigators and research staff on the application and implementation of federal regulations, state laws, and institutional policies and procedures for USF human subjects research. Reviews IRB application submissions for completeness and assign reviewers to the studies.
As federally mandated, conveys all decisions and/or IRB actions in writing to investigators in a clear, concise manner. Creates the federally mandated institutional records in the form of meeting minutes that summarize the discussions and deliberations of the IRB. Creates and maintains the official institutional records, both in an electronic format (computerized data management system) and in physical copies (IRB protocol files), to reflect the actions and decisions of the federally mandated Institutional Review Boards.
Serves as liaison between the Institutional Review Board, the principal investigators, study coordinators, human subjects, and affiliate institutions, providing consultation and guidance to facilitate the ethical and regulatory conduct of human subject research.
Assists in the development of standard operating procedures for the IRB office and the IRB. Assists in the development of Institutional documents utilized by University Researchers. Verifies accuracy of information through a formal internal audit of office research records
Develops and presents educational initiatives to faculty, staff, and students at USF and affiliate sites on the ethical and regulatory requirements of human subject research.
Provides professional consultation and support to the Institutional Review Board on the application and implementation of federal regulations, state laws, and institutional policies to enable it to fulfill its responsibilities in reviewing human subject research.