The Department of Executive Dean of Research is currently seeking a Clinical Research Safety Associate to work in Miami. The Clinical Research Safety Associate (CRSA) supports and assists with safety management and reporting of University of Miami sponsored clinical trials within the Investigator-Initiated Trial Services at the University of Miami. This role involves reviewing and evaluating serious adverse event reports (SAERs) and Adverse Events of Special Interest (AESI) to ensure compliance with regulatory reporting requirements, maintaining adverse event data in safety databases, and drafting narratives. Responsibilities include collaborating with stakeholders to gather additional safety information, preparing regulatory safety reports, monitoring safety literature, and contributing to developing safety policies and risk management plans. The CRSA works closely with clinical research, regulatory affairs, and pharmacovigilance teams to maintain the safety and compliance of investigational products. Core responsibilities include reviewing and evaluating SAERs and AESIs for compliance with regulatory reporting and funding entity requirements; ensuring timely and compliant processing and distribution of event reports; generating queries for study teams; ensuring consistency in investigator causality assessments; maintaining accurate safety data; drafting narratives for regulatory submission; preparing safety reports for regulatory authorities; creating and maintaining study-specific forms; drafting and maintaining safety management plans; contributing to SOPs and risk management plans; assisting with training study teams; participating in safety database setup; compiling safety data for reports and meetings; performing SAE reconciliation; liaising with other units; participating in inspection-readiness activities; supporting Medical Monitor in document review and development; and informing study teams of safety issues and trends. The role requires a Bachelor's degree in health care, science or related field (Master’s preferred), clinical research certification preferred, and minimum 1 year experience with clinical trials. The University of Miami offers competitive salaries and comprehensive benefits.
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