Clinical Research Safety Associate - Hybrid, Miami FL

About the role

The Clinical Research Safety Associate supports safety management and reporting for University of Miami‑sponsored clinical trials within the Investigator‑Initiated Trial Services. The role ensures regulatory compliance, maintains adverse event data, and collaborates with clinical, regulatory, and pharmacovigilance teams.

Key responsibilities

• Review and evaluate Serious Adverse Event Reports (SAERs) and Adverse Events of Special Interest (AESIs) for regulatory and funding compliance.
• Generate queries for study teams to clarify SAE information and ensure consistent causality assessments.
• Maintain accurate safety information in safety databases and trackers for audits and inspections.
• Draft comprehensive narratives for adverse events to support regulatory submissions.
• Prepare and submit safety reports, including MedWatch and CIOMS forms, to regulatory authorities and funding entities.
• Create and maintain study‑specific SAE/AESI forms and safety management plans.
• Contribute to the development and refinement of safety Standard Operating Procedures (SOPs) and risk‑management plans.
• Assist with training study team members on safety processes.

Required profile

• Experience reviewing serious adverse event reports and adverse events of special interest.
• Knowledge of regulatory reporting requirements and funding entity guidelines.
• Ability to collaborate with clinical research, regulatory affairs, and pharmacovigilance teams.
• Strong attention to detail and documentation accuracy.

Required skills

• Safety database management
• Adverse event evaluation
• MedWatch reporting
• CIOMS reporting
• Adverse event narrative drafting
• SAE/AESI form creation
• Safety management plan development
• SOP development