Research Regulations Specialist II

Job description

Location: Health Sciences Center Time Type: Full time Worker Type: Regular Job Req ID: R108570 Minimum Requirements: Bachelor's degree in a related field and two (2) years of relevant experience or an equivalent combination of education and experience. Grade 5 (Hourly) Position Description: The Clinical Trials Program of the Brown Cancer Center is seeking a Research Regulatory Specialist II to provide regulatory support and oversight to clinical trials at the University of Louisville. This position is responsible for preparing research submissions to the IRB of record, maintenance of regulatory approvals and documentation, and providing regulatory guidance to the clinical and administrative staff of the Clinical Trials Program in a manner that demonstrates understanding and application of the federal regulations governing human subjects in research (i.e. 45 CFR 46, 21 CFR 50, 56, 312, 812, ICH GCP, and HIPAA). Essential Duties: Serve as primary regulatory contact with the sponsoring agency for regulatory approvals throughout the life of the project. Serve as primary regulatory contact to the University of Louisville IRB or other IRB of record for the clinical trial. Evaluate the pr...