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Clinical Sample Handling Specialist

TempeOn-siteFull-time

AI Summary

Prepares, labels, verifies, and ships biological samples for clinical studies, ensuring compliance with IATA regulations and client specifications.

About this role

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Essential Functions

  • Prepare samples for shipment, following standard processes and client specifications, to meet predetermined shipping milestones (50%)
  • Reconciliation
  • Sample labeling
  • Sample verification
  • Preparation of sample paperwork, including all SOP required sample tracking, standard or customized manifest creation, accurate deviation reporting and cover letter creations (25%)
  • Pack and ship biological samples both internationally and domestically, following all regulatory requirements and IATA shipping guidelines. (25%)
  • Manage the complete sample management aspect of all assigned studies by working a flexible schedule (including additional hours when needed), cross-checking the work of teammates and proactively communicating with the Clinical Conduct Manager, Clinical Study Manager, Clinical Sample Handling Specialist Team Leader, sponsor contact or receiving laboratory as appropriate
  • Perform process audits
  • Ability to work in required work environment, including but not limited to working in a clinical/ laboratory environment with exposure to biological/ biohazardous materials and second hand smoke from combustible cigarettes and vapors from electronic cigarettes.
  • Other duties as assigned
  • Requirements

  • Post high school education in life sciences or medical training preferred
  • Maintenance of IATA Shipping Certification required.
  • Internal conduct or biological sample inventory experience preferred
  • Ability to communicate professionally with all levels of staff as well as clients
  • Microsoft Office/outlook proficiency
  • Schedule: Monday to Friday 8:00am to 4:30pm (but is flexible after training to meet workload requirements)
  • Skills

    Biological Sample HandlingDeviation ReportingIATA Shipping CertificationManifest CreationMicrosoft OfficeOutlookSample LabelingSample VerificationSOP Compliance

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