Manager, Regulatory Support

About the role

The University of Miami/UHealth Department of SCCC seeks a full‑time Manager, Regulatory Support to lead clinical study compliance and monitoring activities on the UHealth campus in Miami, FL. This position oversees a team of research monitors, ensures adherence to federal and institutional regulations, and provides expert guidance to investigators.

Key responsibilities

• Lead a team of RSQA clinical research monitors for investigational site monitoring and study activities.
• Identify study issues, develop solutions, and engage appropriate decision‑makers.
• Anticipate data needs, assist in database design, and generate study management tools and reports.
• Create and maintain site training documentation, policy manuals, and web‑based resources.
• Contribute to the development of clinical protocols, case report forms, and other study documents; conduct co‑monitoring visits.
• Evaluate data quality, participant safety documentation, and regulatory compliance; monitor legislative changes.
• Produce monitoring reports, follow‑up letters, and track corrective actions.
• Provide expert consultation on quality control and regulatory issues to research sites and investigators.
• Prepare for internal and external audits, ensuring compliance with all applicable regulations.
• Develop and deliver educational programs for the university research community.
• Maintain CAPA system, RSQA databases, and audit files.

Required profile

• Proven experience managing clinical research monitoring teams.
• Strong knowledge of federal, state, and local regulations governing human subject research.
• Ability to develop training materials and policy documentation.
• Experience preparing for and supporting audits.
• Excellent problem‑solving and decision‑making skills.

Required skills

What we offer

• Opportunity to work within a leading academic health institution.
• Collaborative environment with multidisciplinary research teams.
• Professional development and training resources.