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 Requirements 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 Core Competencies 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 Experience Good Clinical Practice (GCP) Regulatory Safety Reporting Clinical Research Certification Medical Data Analysis Hard Skills Adverse Event Data Management Safety Reporting Regulatory Compliance Risk Management Planning Narrative Drafting Clinical Trial Management Software Data Analysis Project Management Attention to Detail Soft Skills Interpersonal Skills Team Collaboration Time Management Organizational Skills Verbal and Written Communication 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 Requirements ICH‑GCP Guidelines Clinical Research Monitoring Tools & Technologies Microsoft Office (Excel, Outlook, PowerPoint, Word) Safety Databases #J-18808-Ljbffr Jobtailor