Clinical Research Safety Specialist

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🔥 12 hours ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟢 Junior

🔬 Research Analyst

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McKesson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1833

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

McKesson is a diversified healthcare leader specializing in pharmaceutical distribution, medical supplies, and healthcare services. Their solutions facilitate patients' access to life-changing therapies, support efficient operations for pharmacies, health systems, and clinics, and address critical issues such as drug shortages through a resilient supply chain. McKesson provides comprehensive services such as pharmacy management software, consulting, and technology solutions for specialty practices, focusing on improving health outcomes and advancing the pharmaceutical industry. They work closely with biopharma companies to enhance medication access, adherence, and commercialization while supporting oncology and biopharma practices through data-driven insights and real-world evidence.

📋 Description

• Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and other applicable oversight bodies. • Maintain and organize IND Safety Reports, Investigator Brochures, and other essential regulatory documentation. • Monitor and support compliance with federal regulations, sponsor requirements, and institutional policies. • Assist with regulatory submissions and ongoing regulatory affairs activities for industry-sponsored and investigator-initiated clinical trials. • Partner with Regulatory Affairs leadership, study teams, and Principal Investigators to ensure regulatory requirements are met. • Support audit and inspection readiness by maintaining complete, accurate, and current regulatory files. • Track deadlines and manage multiple priorities while ensuring timely completion of submissions and compliance-related activities. • Other duties as assigned.

🎯 Requirements

• Bachelor's Degree required • Minimum 1+ years' professional work experience in a clinical research, biotechnology, life sciences, pharmaceutical or hospital environment • Work experience should include knowledge of IRB, FDA, and GCP guidelines required • Work experience of scientific and clinical research terminology required • Above average skills with all MS Office products including Excel, Word, Outlook • Exceptional organizational skills required.

🏖️ Benefits

• Comprehensive benefits to support physical, mental, and financial well-being.