- Functional Area: Research
- Industry: Medical/Healthcare/Hospital
The contractor can be remote, but on site strongly preferred.
The Clinical Safety Specialist will work with other members of the MCO Clinical Safety team located around the world, Clinical Operations, Data Management, Quality Assurance and Regulatory Affairs to manage death and adverse event reporting in compliance with applicable regulatory standards and Medtronic 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 investigational sites and field monitors to obtain additional pertinent information as indicated.
• 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 Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting and other documents as needed.
• Ensures appropriate distribution and notification of SAEs and UADEs to appropriate personnel, partners, and clinical centers for protocol(s).
• Liaison for safety-related questions ( e.g., to study team, field support, monitors, and study sites)
• Write Clinical Safety plan for assigned protocol(s).
• Assists with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required.
• Collaborates with data management and other departments on the development of case report forms, study specific safety reports, and other study specific forms.
• Assists with the writing of safety sections of clinical protocols and may present safety monitoring at investigator meetings.
• 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.
• Bachelor’s degree
YEARS OF EXPERIENCE
• 2+ yrs safety experience
SPECIALIZED KNOWLEDGE REQUIRED
• Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
• Fluent with medical terminology
DESIRED/PREFERRED QUALIFICATIONS (optional)
• RN, PA, PharmD, RPh, PhD, MD, DO, or allied health professional including Biomedical Engineer, Biomedical Scientist.
• Thorough understanding of the general clinical research process with broad knowledge of GCP reporting guidelines, regulatory agency (US and OUS as is appropriate) regulations
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- Name: Mukesh Sharma
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