Clinical Research Safety Associate - Hybrid, Miami FL

University of Miami•Miami, FL

5d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in health care, science or related field required.
Minimum 4 years of experience with clinical trials (involving drugs, biologics or devices) required.
Strong knowledge of Good Clinical Practice (GCP), FDA regulatory requirements and ICH-GCP guidelines
Excellent English skills, both verbal and written
Excellent interpersonal and team skills
Strong attention to detail, time/project management and organization skills
Strong Microsoft Office (Excel, Outlook, PowerPoint, Word) skills
Proficiency in medical data analysis and interpretation.
Proficiency in using clinical trial management software.

Nice To Haves

Master’s degree or higher preferred.
Clinical research certification (e.g. ACRP, SOCRA) preferred
Experience working as a clinical research monitor preferred

Responsibilities

Review and evaluate Serious Adverse Event Reports (SAERs) and Adverse Events of Special Interest (AESIs) for compliance with regulatory reporting and funding entity requirements.
Ensure that reported SAER and AESI event reports are received, tracked, evaluated, processed and distributed/submitted in an efficient and timely manner, and in compliance with regulations, funding entities requirements and IITS-U Safety Management Plans/SOPs.
Generate appropriate queries for study teams to complete and clarify SAE information as needed.
Ensure consistency in investigator causality assessment of SAERs, source documentation, and Reportability Assessment Forms (RAFs) for completeness, accuracy and legibility.
Maintain accurate and up-to-date safety information in safety databases and trackers to ensure proper documentation for audits and inspections.
Draft comprehensive and clear narratives for adverse events to support regulatory submission and study records.
Prepare safety reports, including MedWatch and CIOMS forms, for submission to regulatory authorities and funding entities in a timely and accurate manner.
Prepare safety documentation using requested format by funding entity.
Create and maintain study-specific SAE or AESI forms for study use.
Draft and maintain study specific comprehensive safety management plans, including workflow creation, for investigator-initiated trials to ensure consistent safety oversight.
Contribute to the creation and refinement of safety Standard Operating Procedures (SOPs) and risk management plans to align with Good Clinical Practices.
Assist with training of study team members on the safety reporting expected for the study, including how to complete SAE and/or AESI forms, timelines associated with completing the forms, and how to respond to associated queries on the data submitted.
Participate in the standardized set-up of new safety databases.
Help in compiling safety data required for Project Status Reports, DSMC meetings and other requests as applicable.
Perform SAE reconciliation.
Liaise with other units and departments.
Participate in inspection-readiness activities including documentation needed for eTMF.
Support the Medical Monitor in the review and development of written materials including clinical trial protocols, SAE and AESI reporting forms, and Reportability Assessment Forms.
Inform study team of safety related issues and potential trends and or signals arising from review of data