Clinical Research Compliance Officer
3 weeks ago
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
Safety and Regulatory Expertise
As a Clinical Safety Reporting Specialist, you will be responsible for ensuring compliance with regulatory requirements for clinical study safety data reporting. You will interact with investigational sites and clinical monitors to obtain additional information, work with Regulatory Affairs, Clinical Operations, and Field Assurance to ensure timely reporting of Clinical Safety data, and reply to inquiries from Competent Authorities regarding submitted reports.
Key Responsibilities
- Ensure all Clinical Safety data is assessed consistently against reporting requirements
- Provide input to or assist with preparation of assigned sections of Clinical Safety Management and Potential Complaint Plan, Clinical Investigation Plan, Clinical Study Reports, Investigator Brochure, Case Report Forms, and other documents as required
- Support study audit for Clinical Safety-specific topics
Requirements and Qualifications
- Bachelor's degree with 2+ years of clinical research experience or advanced degree with no experience
- Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
- Fluent with medical terminology
Compensation and Benefits
Medtronic offers a competitive salary range of $80,000 - $120,000 per year, flexible benefits package, and a commitment to our employees' lives and well-being.
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