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Provides regulatory support for UTHealth researchers including Investigational New Drug (IND) and Investigational Device Exception (IDE) submissions, and Data Safety Monitoring Board (DSMB) and clinical trials registration.
Additional Summary Specific to Job
Primary responsibilities include:
- Assists the Institutional Research Board (IRB) and researchers in determining whether an IND/IDE is required; and when required, assist researchers in preparing and submitting the IND/IDE application.
- Conducts clinical research billing audits to ensure that clinical trials are being billed appropriately.
- Leads the institutional effort to meet FDAA clinical trials registration requirements by identifying clinical trials that need to be registered, and assisting researchers with registration, updating results, and resolving problems with records.
- Assists in developing and implementing a comprehensive quality improvement initiative for regulatory review of research at UTHealth, including IRB post-approval monitoring.
- Assists in educational programs related to regulatory issues, including developing training programs, conducting training, and developing online training modules.
- Other duties as assigned.
Bachelor's degree in a basic science with a minimum of four years of clinical trial regulatory affairs experience. Master's degree preferred.
Regulatory Affairs Certification (RAC), Certified Clinical Research Professional (CCPR), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP) preferred.
Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth)...