Sample Management Specialist

Caris Life Sciences•Phoenix, AZ

1d•Onsite

About The Position

The Sample Management Specialist plays a critical role in ensuring the integrity, traceability, and operational excellence of specimen management activities supporting research and organizational initiatives. This position is responsible for the lifecycle management of remnant biological specimens following diagnostic testing, including specimen receipt from Laboratory Operations, inventory management, storage, tracking, retrieval, request fulfillment, de-identification, distribution, and disposition. The Specialist ensures all specimen-related activities are performed in accordance with established Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), regulatory requirements, and organizational quality standards while collaborating with cross-functional stakeholders to support research and operational objectives.

Requirements

Associate degree or higher in Biological Sciences or a related scientific field, or equivalent combination of education and relevant experience.
Minimum of one year of experience handling human biological specimens within a laboratory, clinical research, healthcare, or related scientific environment.
Minimum of one year of experience with specimen inventory management, chain of custody documentation, specimen tracking, and data management.
Proficiency with Laboratory Information Management Systems (LIMS), Sample Management Systems, and Microsoft Office applications.
Strong attention to detail with demonstrated ability to maintain accurate documentation and data integrity.
Excellent organizational, prioritization, and time management skills with the ability to manage multiple competing priorities.
Strong verbal and written communication skills with the ability to collaborate effectively across multidisciplinary teams.
Demonstrated problem-solving skills and commitment to continuous improvement.
Ability to work on-site to support specimen management operations.

Nice To Haves

Familiarity with regulatory requirements governing sample management practices in clinical and research settings (e.g., CLIA, CAP, FDA).
Previous experience in a Biorepository setting or Clinical Trial setting.
Laboratory Information Management System or Sample Management System experience.
Customer service experience.
Good Clinical Practice training, IATA training, and Human Subject Protection training.

Responsibilities

Receive remnant biological specimens from clinical and research testing, check specimens into the Laboratory Information Management System (LIMS), inventory and file specimens in appropriate storage locations, retrieve and distribute specimens in support of research activities, fulfill approved specimen requests, and coordinate specimen disposition while maintaining chain of custody and specimen integrity throughout the specimen lifecycle.
Review and process specimen requests to ensure required approvals are obtained, evaluate specimen availability, maintain complete chain of custody documentation, coordinate request fulfillment activities, and communicate specimen availability and request status with internal stakeholders while ensuring compliance with organizational policies and research requirements.
Manage specimen inventory through accurate cataloging, tracking, reconciliation, storage, retrieval, transfer, and distribution activities. Monitor specimen influx, storage capacity, and environmental conditions to preserve specimen quality and ensure accurate accounting of remnant specimen inventory.
Coordinate specimen receipt of both clinical and research samples, transfer, storage, distribution, and disposition activities while maintaining complete documentation and chain of custody throughout specimen movement and storage processes.
Coordinate and perform specimen de-identification activities to protect patient confidentiality while maintaining specimen traceability, data integrity, and compliance with applicable privacy regulations and research protocols. Support de-identified specimen requests for research and operational purposes.
Accurately enter and maintain specimen information within Laboratory Information Management Systems (LIMS) and Sample Management Systems, including specimen receipt, inventory status, storage location, retrieval, transfers, distribution, chain of custody, and disposition. Maintain complete and accurate documentation to support specimen tracking, operational reporting, inventory reconciliation, and audit readiness.
Participate in quality assurance activities through documentation review, data verification, inventory reconciliation, workflow audits, corrective actions, and continuous monitoring to ensure specimen integrity, regulatory compliance, and adherence to SOPs, GCP, CLIA, CAP, FDA, HIPAA, and organizational quality standards.
Identify opportunities to improve specimen management workflows, inventory processes, documentation practices, and supporting technologies to enhance operational efficiency, quality, customer service, and regulatory compliance while maintaining specimen integrity.
Collaborate with Laboratory Operations, research scientists, quality assurance personnel, Clinical Operations, and other internal stakeholders to coordinate specimen management activities, communicate specimen status, resolve operational issues, and support research and organizational initiatives.
Communicate clearly and professionally regarding specimen availability, request fulfillment, inventory status, operational issues, and process updates while providing exceptional customer service and timely resolution of inquiries.
Effectively prioritize competing specimen management activities, manage multiple requests simultaneously, maintain accurate documentation, and consistently meet established turnaround times and operational deadlines.
Identify, investigate, and resolve specimen discrepancies, inventory issues, documentation errors, equipment concerns, and workflow deviations to maintain specimen integrity and operational continuity.
Respond effectively to changing business priorities, fluctuating specimen volumes, specialized research requests, evolving technologies, and process improvements while maintaining compliance and quality standards.
Work collaboratively with laboratory, research, quality, and operational teams to coordinate specimen-related activities, share knowledge, support departmental initiatives, and contribute to a positive team environment.
Demonstrate proficiency with Laboratory Information Management Systems (LIMS), Sample Management Systems, Microsoft Office applications (including Excel), and other laboratory technologies while maintaining knowledge of emerging specimen management tools and best practices.
Other additional duties as assigned