Posted 3 years ago in Biotech/Pharmaceutical
REGISTERED NURSE WITH CURRENT LICENSE REQUIRED.
POSITION DESCRIPTION: The Clinical Safety Specialist will work with other members of the Clinical Safety team, Clinical Operations, Data Management, Quality Assurance and Regulatory Affairs to manage death and adverse event reporting in compliance with applicable regulatory standards and internal requirements.
•Review and triaging clinical trial deaths and adverse events (AEs) including serious adverse events (SAEs).
•Conduct Case Management in the Clinical Safety Database.
•Interacts with Clinical Trial teams and/or field monitors to obtain additional pertinent information as needed.
•Works with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events (e.g., SAEs , adverse events (AEs), and device deficiencies).
•Works with Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting and other documents as needed.
•Liaison for safety-related questions ( e.g., to study team, field support, monitors, and study sites)
•Performs other duties as assigned.
•Good written, oral, and interpersonal communication skills including knowledge of medical terminology.
•Proficient with MS Office products, word processing, spreadsheets, etc.
•High attention to detail and accuracy and ability to manage multiple tasks.
•Good prioritization and organizational skills.
•Excellent problem solving skills
•Flexible and dependable.
•Works effectively on cross-functional teams.
Three Point Solutions is a professional staffing firm that offers contract staffing, contract to hire and permanent placement services for our clients professional resource needs.
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