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Clinical Safety Monitor Jobs (NOW HIRING)

Conduct Clinical Safety monitoring activities for assigned clinical studies to proactively identify/review/track reportable safety events, identify safety event trends/signals, issue and address data ...

Position: Sr. Clinical Safety Specialist Location: Los Gatos, CA Job Id: 674 # of Openings: 1 ... monitoring plan. Using MedDRA coding, code adverse events. * Narrative Writing: Author clear ...

The Sr. Clinical Safety Specialist is responsible for the clinical review and medical assessment of ... monitoring plan. Using MedDRA coding, code adverse events. * Narrative Writing: Author clear ...

At Emmes Group , we're shaping the future of clinical research- where human intelligence meets ... The Senior Safety Monitor I will be responsible for safety monitoring for interventional and non ...

At Emmes Group , we're shaping the future of clinical research- where human intelligence meets ... The Senior Safety Monitor I will be responsible for safety monitoring for interventional and non ...

The Sr. Clinical Safety Specialist is responsible for the clinical review and medical assessment of ... monitoring plan. Using MedDRA coding, code adverse events. * Narrative Writing: Author clear ...

Monitoring of safety-related queries to Investigators. * In collaboration with medical monitor, plans and executes the plan for study safety review. * Provides safety overview to the clinical team ...

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Clinical Safety Monitor

Maple Grove, MN • On-site

Other

Posted 8 days ago


Job description

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.