McKesson
McKesson

McKesson is a healthcare company operating across pharmaceutical distribution, medical supplies, and healthcare services. Its work helps pharmacies, clinics, health systems, and patients access essential therapies while supporting more efficient healthcare operations and a resilient response to drug shortages.

The company also develops pharmacy management software, consulting, and technology solutions for specialty practices. McKesson works with biopharma organizations and supports oncology and biopharma practices through services focused on medication access, adherence, commercialization, data-driven insights, and real-world evidence.

Clinical Project Associate — Tennessee Remote

Support oncology clinical research at SCRI by maintaining audit-ready Trial Master Files and coordinating essential site documentation. Help resolve regulatory issues and deliver accurate clinical trial documentation throughout the study lifecycle.

Description

  • Establish the Trial Master File (TMF/eTMF) and gather and upload required documents
  • Conduct preliminary quality checks before documents are filed in the TMF/eTMF
  • Work with document specialists to keep the TMF audit-ready throughout the study
  • Help verify investigator and investigative-site qualifications
  • Distribute and retrieve essential documents from investigative sites during the trial
  • Coordinate with Clinical Research Associates and investigative sites to address unresolved regulatory issues
  • Check study documents for currency, completeness, and accuracy
  • Contribute to cross-functional teams supporting project deliverables
  • Maintain clinical trial management systems and study tracking tools
  • Collect and review documentation throughout the study in line with applicable guidelines and regulations
  • Handle additional responsibilities as assigned

Requirements

  • High school diploma or GED required
  • At least one year of clinical research experience required
  • Oncology clinical research experience preferred
  • Three or more years of clinical research experience preferred
  • Working knowledge of Good Clinical Practice, ICH Guidelines, federal regulations, and Development Innovations SOPs
  • Applicants must be based in the United States
  • Experience using clinical trial management systems and tracking tools required

Benefits

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

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