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Clinical Project Associate

🔥 0 minutes ago

🎸 Tennessee – Remote

infoinfo

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

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Logo of McKesson

McKesson

10,000+ employees

Founded 1833

đź’Ľ Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

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.

đź“‹ Description

• Ensure the Trial Master File (TMF) is set up and maintained in audit-ready condition • Collect, upload, and perform initial quality review of TMF/eTMF documents • Partner with document specialists to maintain the TMF from study start to completion • Assist with confirming investigator and investigative site qualifications throughout clinical trials • Distribute and collect critical documents from investigative sites throughout the clinical trial lifecycle • Liaise with Clinical Research Associates and investigative sites to resolve outstanding regulatory issues • Review study documents to ensure they are current, complete, and accurate • Maintain clinical trial management systems and tracking tools • Participate in cross-functional teams to ensure delivery of project deliverables • Perform other duties as assigned

🎯 Requirements

• Minimum High School Diploma or GED • At least 1 year of clinical research experience required • Oncology clinical research experience preferred • At least 3 years of clinical research experience preferred • Knowledge of Good Clinical Practices, ICH Guidelines, Federal Regulations, and Development Innovations SOPs • Must be based in the United States • Must be able to maintain clinical trial management systems and tracking tools • Must be able to conduct Trial Master File/eTMF documentation collection, review, and filing • Must be able to confirm investigator and investigative site qualifications

🏖️ Benefits

• Comprehensive benefits supporting physical, mental, and financial well-being • Annual bonus or long-term incentive opportunities may be offered • Relocation assistance is not available • Visa sponsorship is not available

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