Quality Assurance/Quality Improvement Compliance Auditor RCA II

Quality Assurance/Quality Improvement Compliance Auditor Research Compliance Administrator (RCA) IIThe Quality Assurance/Quality Improvement (QA/QI) Compliance Auditor Research Compliance Administrator (RCA) II position will conduct random monitoring and for-cause audits of Institutional Review Board (IRB) approved studies for compliance with federal regulations, state law, AAHRPP accreditation standards, and USF policies and procedures related to the protection of human subjects in research. This position will also conduct continuous monitoring of the IRB, including conducting audits of IRB minutes and IRB records, to ensure compliance with federal regulations, AAHRPP accreditation standards and USF policies and procedures. This position requires extensive written and oral communication between the Quality Assurance/Quality Improvement (QA/QI) Program, Human Research Protection Program (HRPP)/IRB, the Conflict of Interest Program, and Principal Investigators and research teams.ResponsibilitiesThe duties and responsibilities for this position include:40% - Monitors the performance of randomly-selected USF IRB-approved protocols and performs for-cause audits (situations of known or suspected noncompliance with federal regulations, state laws, AAHRPP-accreditation standards, and/or HRPP/IRB policies and procedures) of human participant research.25% - Serves as a liaison between the human subject researchers and the Institutional Review Board (e.g., assisting investigators with corrective and preventative action plan development, presenting monitoring activities results to the IRB, etc.).15% - Performs quality assurance/quality improvement assessments of the HRPP, including auditing IRB minutes, IRB records and monitoring compliance with COI management plans.10% - Perform QA/QI educational outreach initiatives (e.g. best practices training regarding regulatory records maintenance, helping researchers prepare for external site visits (sponsor monitoring visits, FDA audits, etc.)5% - Provides data management support for the Quality Improvement documentation (e.g., maintain QI files; keeps QI tracking files updated; and keeps QI file log up-to-date).5% - Assists the QA/QI Program Manager with special projects. Performs other duties as assigned.5% - Performs other duties as assigned to support department and unit needs.QualificationsMinimum QualificationsThis position requires a Bachelor's degree and four years of experience in research or research administration; or a Master's degree and two years of experience in research or research administration. Four years of progressively responsible work experience in research or research administration may substitute for the Bachelor's degree.• Senate Bill 1310- The Florida Senate ( is conditional upon meeting all employment eligibility requirements in the U.S.• SB 1310: Substitution of Work Experience for Postsecondary Education Requirements• A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed:(a) Two years of direct experience for an associate degree;(b) Four years of direct experience for a bachelor's degree;(c) Six years of direct experience for a master's degree;(d) Seven years of direct experience for a professional degree; or(e) Nine years of direct experience for a doctoral degree• Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment.• Minimum Qualifications that require a high school diploma are exempt from SB 1310.Preferred QualificationsMaster's degree in health administration or similar field relating to health care research and/or human subjects research administration/management. Experience as a study coordinator, IRB staff member, or monitoring and/or auditing human subjects research desired. Data management software as well as USF Business Enterprise applications (GEMS, OASIS, Click Commerce) experience is a plus.Additional Information for ApplicantsThis position requires a Level I background check.The hiring salary range for this position is: $56,966 - $71,207.50 University of South Florida