Research Compliance Admin I

About the role

This position applies and implements 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.

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 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.
• Affords assistance in the development of standard operating procedures for the IRB office and the IRB.
• Affords assistance 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.

Qualifications

• Minimum Qualifications: A Bachelor’s degree and two years of experience in research or research administration; or a Master’s degree.
• Additional Qualifications: Four years of progressively responsible work experience in research or research administration may substitute for the Bachelor’s degree.