[Remote] Sr. Clinical Safety Specialist (Remote)
Note: The job is a remote job and is open to candidates in USA. Stryker Inari is seeking a Sr. Clinical Safety Specialist to ensure accurate, timely, and consistent safety assessments of adverse events across sponsored clinical studies and registries. This role focuses on consistent evaluation, documentation, and reporting of adverse events in alignment with global requirements while collaborating across study teams and external partners.
Responsibilities
- Review adverse events, serious adverse events, and endpoint-related events across clinical studies to ensure accurate assessment and documentation
- Prepare clinical safety narratives using source documents and study data, completing deliverables within defined timelines and quality standards
- Collaborate with clinical sites and monitors to request, collect, and verify source documentation required for adjudication
- Apply MedDRA coding to adverse events to ensure standardized classification and consistency across studies
- Coordinate with study teams, medical monitors, and adjudication committees to support protocol-aligned safety reviews
- Contribute to safety management plans for assigned protocols and support safety review meetings with documented findings
- Monitor safety data quality by identifying discrepancies and implementing corrective actions to maintain completeness and accuracy
- Maintain compliance with Good Clinical Practice and regulatory requirements through adherence to standard operating procedures and audit readiness
Skills
- Bachelor's degree
- 2+ years of clinical research experience
- Experience applying Good Clinical Practice standards in clinical trials
- Proficient with electronic databases used for clinical trials such as, Zelta, etc
- Bachelor's degree in life science or related field
- 2-4 years of experience in medical device clinical trials
- Experience with adverse event review, safety reporting, or pharmacovigilance processes
- Knowledge of MedDRA coding standards
- Possesses exceptional attention to detail and strong analytical skills to accurately review CRFs, source documents, and evaluate safety data for quality and compliance
- Brings medical knowledge and preferably experience in clinical trials or medical devices to support informed decision-making and data integrity
Benefits
- Medical and prescription drug insurance
- Dental insurance
- Vision insurance
- Critical illness insurance
- Accident insurance
- Hospital indemnity insurance
- Personalized healthcare support
- Wellbeing program
- Tobacco cessation program
- Health Savings Account (HSA)
- Flexible Spending Accounts (FSAs)
- 401(k) plan
- Employee Stock Purchase Plan (ESPP)
- Basic life and AD&D insurance
- Short-term disability insurance
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