Clinical Sample Handling Specialist
PharmaBiotechClinical ResearchRegulatory Affairscro
Job description
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)
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