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Clinical Research Safety Associate
University of MiamiClinical 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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in safety management and reporting for clinical trials, with a strong focus on regulatory compliance, adverse event evaluation, and collaboration with cross-functional teams. Proficient in medical data analysis and interpretation, ensuring adherence to Good Clinical Practice and FDA regulatory requirements.
Highest-signal resume keywords
Clinical Trials ExperienceGood Clinical Practice (GCP)Regulatory Safety ReportingClinical Research CertificationMedical Data Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
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
Tools & Technologies
Microsoft Office (Excel, Outlook, PowerPoint, Word)Safety Databases
Certifications & Qualifications
Clinical Research Certification (ACRP, SOCRA)Bachelor’s Degree in Health Care or Science
Industry Keywords
Adverse Events of Special Interest (AESI)Serious Adverse Event Reports (SAERs)FDA Regulatory RequirementsICH-GCP GuidelinesClinical Research Monitoring
Tech Stack
Tools & technologiesGoogle 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