QA/QI Research Compliance Admin II

University of South Florida • Tampa, FL

1d • $56,966 - $61,000

About The Position

The Quality Assurance/Quality Improvement (QA/QI) ClinicalTrials.gov (CT.gov) Research Compliance Administrator (RCA) II position will support the resolution of common and complex CT.gov compliance issues for the university’s CT.gov organizational account. This position will also conduct continuous monitoring of Institutional Review Board (IRB) approved studies for compliance with federal regulations, state law, the Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation standards and USF policies and procedures related to the protection of human subjects in research. This position requires knowledge of FDA IND and IDE study procedures, FDAAA and ACT CT.gov requirements, and federal research regulations. Must have extensive written and oral communication skills for appropriate rapport between the QA/QI Program, HRPP/IRB, the Conflict of Interest Program, Sponsored Research and Principal Investigator (PI) and research teams.

Requirements

• This position requires a Bachelor’s degree and four years’ 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 experience in research or research administration may be substituted for the Bachelor’s degree.
• Experience as a study coordinator, IRB staff member, or monitoring and/or auditing human subjects research desired.

Nice To Haves

• This position requires knowledge of research compliance federal regulations, familiarity with Florida research state laws, and AAHRPP accreditation standards as well as Institutional policies and procedures related to the protection of human subjects in research.
• This position requires knowledge of FDA IND and IDE study procedures, as well as FDAAA and ACT CT.gov requirements.
• Familiarity with research data management software (Oracle, OASIS, Click Commerce, and/or Huron) experience is desired.
• Extensive written and oral communication skills as well as excellent organizational and problem solving skills are also preferred.

Responsibilities

• Support the resolution of common and complex CT.gov compliance issues for the university’s CT.gov organizational account including registering new CT.gov users, providing guidance to Investigator's on identifying and correcting data errors, assisting with CT.gov record transfers, as appropriate, sending reminder notifications to Investigator's regarding outstanding CT.gov requirements and deadlines, etc: (45%).
• Monitors the performance of USF IRB approved protocols of human participant research and serves as a liaison between the human subjects researchers and the IRB (e.g. assisting investigators with corrective and preventative action plan development, presenting monitoring activities results to the IRB etc.): (35%).
• Performs QA/QI educational outreach initiatives (e.g. best practices training regarding regulatory records maintenance, helping researchers prepare for external site visits, such as FDA inspections, etc.): (10%).
• Provides data management support for the QA/QI documentation (e.g. maintain QA/QI files, keep QA/QI tracking files updated and keep QA/QI file log up to date): (5%).
• Assist the QA/QI Program Manager with special projects and performs other duties as assigned: (5%).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees