About The Position

Celerion is seeking a Clinical Sample Handling Specialist to manage the sample-handling aspects of assigned clinical studies. The role prepares, verifies, labels, reconciles, documents, packs, and ships biological samples in accordance with established processes, client specifications, regulatory requirements, and IATA shipping guidelines. The specialist works with a flexible schedule as workload requires, checks teammates’ work, communicates proactively with study teams and external contacts, and performs process audits. The work may involve a clinical or laboratory environment and exposure to biological or biohazardous materials, secondhand smoke from combustible cigarettes, and vapors from electronic cigarettes.

Requirements

  • Maintenance of IATA Shipping Certification is required.
  • Ability to communicate professionally with all levels of staff and with clients.
  • Proficiency with Microsoft Office and Outlook.

Nice To Haves

  • Post-high-school education in life sciences or medical training is preferred.
  • Internal conduct or biological sample inventory experience is preferred.

Responsibilities

  • Prepare samples for shipment according to standard processes and client specifications, meeting predetermined shipping milestones.
  • Reconcile, label, and verify samples.
  • Prepare sample paperwork, including SOP-required tracking, standard or customized manifests, deviation reports, and cover letters.
  • Pack and ship biological samples domestically and internationally in accordance with regulatory requirements and IATA shipping guidelines.
  • Manage the sample-handling aspects of assigned studies, working a flexible schedule and additional hours when needed.
  • Cross-check teammates’ work.
  • Proactively communicate with the Clinical Conduct Manager, Clinical Study Manager, Clinical Sample Handling Specialist Team Leader, sponsor contacts, and receiving laboratories as appropriate.
  • Perform process audits.
  • Carry out other duties as assigned.
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