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Biotechnology, Pharmaceuticals, Clinical Research

Clinical Sample Handling Specialist

Tempe, AZOnsiteFull TimePosted 17 days agoVisa sponsorship available

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Required skills

  • biological samples
  • sample management
  • sample labeling
  • sample verification
  • manifest creation
  • deviation reporting
  • Microsoft Office
  • Outlook

Nice to have

  • life sciences
  • medical training
  • internal conduct
  • biological sample inventory

Role summary

Celerion is seeking a Clinical Sample Handling Specialist to manage the preparation, packing, and shipping of biological samples for clinical research studies. This role involves ensuring compliance with standard processes, client specifications, and international shipping regulations (IATA). Responsibilities include sample labeling, verification, paperwork preparation, and maintaining accurate tracking and deviation reporting. The specialist will also perform process audits and collaborate with various stakeholders, including clinical managers and sponsors. A flexible schedule and ability to work in a clinical/laboratory environment with biological materials are required. Post-high school education in life sciences or medical training and IATA Shipping Certification are preferred.

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)
  • Celerion Values: Integrity Trust Teamwork Respect Are you ready to join our team? Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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