Clinical Research Safety Associate

Jobtailor; Miami (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Jobtailor is seeking a dedicated Clinical Safety Monitor to oversee safety reporting and regulatory submissions for trials. You will evaluate adverse events, maintain safety databases, and draft narratives for safety reports, ensuring compliance with GCP and FDA requirements.

Ideal candidates hold a health science degree with 4+ years in clinical trials, certifications preferred, and strong communication and collaboration skills across cross-functional teams.

Qualifications

• Bachelor’s degree in health care, science or related field required.
• Master’s degree or higher preferred.
• Clinical research certification (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

Responsibilities

• Supports and assists with safety management and reporting of clinical trials.
• Reviews and evaluates SAEs and AESIs.
• 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.

Skills

Clinical trials

GCP knowledge

Regulatory compliance

Medical data analysis

Narrative drafting

Project management

Microsoft Office

Communication

Team collaboration

Attention to detail

Education

Bachelor’s degree in health care or science

Master’s degree preferred

Tools

Clinical trial management software

Microsoft Office

Safety databases

Job description

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