Clinical Research Safety Associate

University of Miami

Clinical Research Safety Associate managing adverse event reporting for University of Miami clinical trials. Collaborating with stakeholders on safety policies and ensuring regulatory compliance in Miami office.

Posted 7/10/2026full-timeMiami • Florida • 🇺🇸 United StatesJuniorMid-LevelWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Supports and assists with safety management and reporting of clinical trials
Reviews and evaluates serious adverse event reports (SAERs) and Adverse Events of Special Interest (AESI)
Maintains adverse event data in safety databases
Drafts narratives for regulatory safety reports
Collaborates with stakeholders to gather additional safety information
Prepares regulatory safety reports and monitors safety literature
Contributes to developing safety policies and risk management plans
Works closely with clinical research, regulatory affairs, and pharmacovigilance teams to maintain compliance
Conducts training for study team members on safety reporting

Requirements

What you’ll need

Bachelor’s degree in health care, science or related field required
Master’s degree or higher preferred
Clinical research certification (e.g. ACRP, SOCRA) preferred
Minimum 4 years of experience with clinical trials (involving drugs, biologics or devices) required
Experience working as a clinical research monitor preferred
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.

Benefits

Comp & perks

medical
dental
tuition remission

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Adverse Event Data ManagementSafety ReportingRegulatory ComplianceRisk Management PlanningNarrative DraftingClinical Trial Management SoftwareData AnalysisProject ManagementAttention to Detail

Soft Skills

Interpersonal SkillsTeam CollaborationTime ManagementOrganizational SkillsVerbal and Written Communication

Certifications

Clinical Research Certification (ACRP, SOCRA)Bachelor’s Degree in Health Care or Science