Clinical Safety Monitor
Location: Maple Grove, MN (Onsite)
Experience: 5+ years
Role Summary
The Safety Monitor ensures that clinical studies are planned and conducted in compliance with applicable regulations, Good Clinical Practices, and standard operating procedures. The primary focus of this role is the processing and review of adverse events, ensuring the consistency, completeness, and regulatory compliance of safety data for assigned studies.
Key Responsibilities
• Processes all adverse events per the Clinical Investigational Plan (CIP) and applicable Work Instructions, ensuring regulatory and CIP compliance in safety data processing.
• Reviews adverse events in a timely manner for consistency and completeness of safety data.
• Ensures source documents related to submitted adverse events are reviewed per the Safety Plan; confirms consistency between source documents and safety data points; creates and processes safety data queries for inconsistent or ambiguous data.
• Collaborates with study-specific Safety CRAs to ensure comprehensive information is available for Clinical Event Committee (CEC) review and adjudication.
• Assists in drafting the Safety Plan for assigned studies.
• Assists in reconciliation between submitted adverse events and product complaints, and between adverse events and other related forms per the Safety Plan.
• Acts as the safety representative for the Clinical Study team; serves as a liaison to project management and site personnel on safety-related issues.
• Reviews and provides comments on safety-related study documents.
• Supports follow-up and resolution of safety data findings from monitoring visits and audits.
• Develops and maintains knowledge of regulations and guidelines for classifying and reporting adverse events.
• May contribute to the development of safety documents and guidance for the safety team.
Required Qualifications
• Bachelor’s degree in medicine, pre-medicine, nursing, life science, bioengineering, or a related field.
• Minimum 2 years of clinical research experience.
• Understanding of medical terminology.
• Ability to interpret basic safety data and communicate findings effectively across all levels.
• Strong written and verbal communication, interpersonal, presentation, and organizational skills.
• Ability to work independently while seeking guidance when appropriate.
• Proficiency in Microsoft Office Suite and relevant clinical applications.
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