Clinical Coordinator, Sample Logistics

Clinical Coordinator, Sample Logistics

Position Description:

The Clinical Coordinator will partner with clinical operations, translational research and pharmacology team members to implement and manage clinical sample logistics, including oversight of tracking, collection materials and laboratory operational plans. This position requires a combination of scientific and project management expertise as they will be responsible for the support of clinical laboratory functions within clinical trials; Includes operational support for, laboratory supplies needs, clinical testing schedules, and lab manual creation or review.

Responsibilities:

  • Ensure the chain of custody for the samples is maintained by management of end-to-end sample tracking and logistics for clinical samples, working closely with the central and specialty lab vendors as well as a sample tracking and data management vendor
  • Identify, triage, and resolve laboratory sample queries to ensure sample and data integrity
  • Develop and/or maintain relevant trackers to ensure laboratory sample end-to-end reconciliation of collection, shipment and facility testing or storage facilities records
  • Ensure oversight of sample use, destruction or return according to informed consent for each study site and subject
  • Monitor trends and quality metrics as they relate to clinical site sample collection, processing and shipment errors
  • Ensure laboratory documents are filed appropriately in the eTMF
  • Develop and/or maintain laboratory documentation (tracking documents, shipment forms, manuals) in an organized manner
  • Review and manage laboratory supplies at site to ensure adequate supplies are maintained
  • Assist with creating site and team training tools as they relate to clinical laboratory operations
  • With support of clinical operations, translational research, clinical pharmacology assist in oversight of testing laboratories, specimen storage laboratories, kit development services, and other logistics services

Candidate requirements:

  • Bachelor’s degree with science focus
  • Experience managing clinical laboratory study startup, oversight and reconciliation
  • LIMs experience/familiarity preferred
  • 2+ years experience in clinical operations or equivalent discipline with a focus on clinical laboratory management
  • Strong verbal and written communication skills
  • Excellent interpersonal and organizational skills
  • Ability to deal with competing priorities
  • Strong reasoning, detail orientation and problem-solving abilities are essential
  • Ability to work on teams and on multiple concurrent projects, and works well under general direction
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Clinical Coordinator, Sample Logistics

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