Clinical Project Associate

Job not on LinkedIn

🔥 2 hours ago

🎸 Tennessee – Remote

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⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

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👻 Ghost score 10%

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Logo of McKesson

McKesson

10,000+ employees

Founded 1833

💼 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.

📋 Description

• Set up the Trial Master File (TMF/eTMF) and collect and upload documents • Perform initial quality reviews of documents before TMF/eTMF filing • Partner with document specialists to maintain the TMF in audit-ready condition throughout the study • Assist with confirming investigator and investigative-site qualifications • Distribute and collect critical documents from investigative sites throughout the clinical trial • Liaise with Clinical Research Associates and investigative sites to resolve outstanding regulatory issues • Review study documents for currency, completeness, and accuracy • Participate in cross-functional teams to support project deliverables • Maintain clinical trial management systems and tracking tools • Conduct documentation collection and review throughout the study lifecycle in accordance with applicable guidelines and regulations • 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 US • Must be able to work with clinical trial management systems and tracking tools

🏖️ 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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