Research Compliance Admin II

University of South Florida•Tampa, FL

About The Position

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. Organizational Unit The Division of Research Integrity & Compliance (RIC) is a unit within the USF system vice presidential area, Office of 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 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 Reviews incoming social-behavioral and biomedical human subjects research applications for completeness, assigns IRB designated reviewers, and completes post-review activities for expedited and exempt studies. Conducts pre-reviews for social-behavioral and biomedical human subjects full committee research, non-committee research, and non-human subjects research. Serves as a consultant and liaison to the research community, IRB members, and investigators regarding federal regulations, state laws, and institutional policies. Additional duties may be assigned as experience and skill determines.

Requirements

This position requires a Bachelor's degree and four years of experience in research or research administration; or a Master's degree with two years of experience in research or research administration.
Four years of progressively responsible work experiencing research or research administration may substitute for the Bachelor's degree.

Nice To Haves

Experience working with direct Institutional Review Board (IRB) administration and/or federally mandated record management.
Three years experience and knowledge of USF IRB policies, procedures and processes.
Computerized data management software as well as USF Business Enterprise applications (ORACLE, OASIS and ARC) experience highly desired.
Experience in a large university setting is preferred.
Certified IRB Professional (CIP), SOCRA, CCRC and/or ACRP certification.

Responsibilities

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 assigns 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, completion of AAHRPP accreditation activities, and preparation for federal inspections.
Assists in the development of Institutional documents utilized by University Researchers.
Assist with additional responsibilities, as assigned. These responsibilities may relate to assisting the Reliance Manager with external applications, sIRB applications, and/or HIPAA Office with HIPAA reviews, as applicable.
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.
Performs other duties as assigned.