Clinical Research Safety Associate

Responsibilities

• 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

• 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

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.

• Clinical Trials Experience
• Good Clinical Practice (GCP)
• Regulatory Safety Reporting
• Clinical Research Certification
• Medical Data Analysis

• Adverse Event Data Management
• Safety Reporting
• Regulatory Compliance
• Risk Management Planning
• Narrative Drafting
• Clinical Trial Management Software
• Data Analysis
• Project Management
• Attention to Detail

• Interpersonal Skills
• Team Collaboration
• Time Management
• Organizational Skills
• Verbal and Written Communication

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

• Adverse Events of Special Interest (AESI)
• Serious Adverse Event Reports (SAERs)
• FDA Regulatory Requirements
• ICH‑GCP Guidelines
• Clinical Research Monitoring

• Microsoft Office (Excel, Outlook, PowerPoint, Word)
• Safety Databases