Time as Reported Grade 000 Dept Desc Responsibilities Position Summary Under direction from the Clinical Trials Specimen Logistics Operations Coordinator and Department Manager, and with some latitude for independent judgment, supports daily activities maintaining laboratory and equipment (centrifuges, refrigerators, and freezers), receives and accessions biological specimens for multi-center clinical trials and internal clinical research projects for the clinical trials central laboratory (CTCL, performs necessary processing (centrifuging, aliquoting, freezing), and triages specimens for analysis or storage. Identifies and documents non-conforming specimens and associated paperwork. Print forms and labels, track, package and ship biological specimens. Perform general clerical functions (file, copy, fax, and scan) to support to CTCL staff and clinical trials and research projects. Follows project specifications and communicates specimen related information to project management, laboratory sections and external reference laboratories. Communicates roadblocks and identifies opportunities for process improvement. Perform all work in compliance with Good Clinical Practices (GCP) Job Responsibilities Receive, Accession and Triage Biological Specimens Enter and maintain accurate specimen information in the Clin Axys II laboratory information system. Identify and document non-conforming and/or discrepant materials and paperwork Create orders in SoftLab LIS for non-interfaced testing Create and manage specimen tracking lists, logs, and manifests Package biological specimens for shipment in accordance with all applicable regulations such as DOT (Department of Transportation) and IATA (International Air Transport Association) regulations Maintain Biorepository storage specimens Enter specimens into short and long term storage, recording exact physical locations in the ClinAxys II system Retrieve specimens as necessary for analysis or shipment to other facilities Accurately record all sample movements to provide traceability for specimen locations and status (thawed, re-frozen, extracted to DNA, reviewed by pathologist, etc) Support daily operations for research studies and clinical trials Answer telephone and e-mail inquiries from internal departments regarding specimens. Communicate project indicators to project management. Assist with the design of forms and labels required to identify samples submitted for testing. Track delivery of inbound packages through FedEx Participate in client tours and regulatory inspections Maintain laboratory and associated equipment Complete daily checklist for maintaining a clean and safe work environment Perform routine maintenance of laboratory equipment such as centrifuges, pipets, refrigerators and freezers Identify equipment or facility issues and report them to management Maintain all records in an audit-ready state Other duties and projects as assigned. Functional Requirements: Ability to manage multiple competing priorities and projects. Ability to interact effectively and professionally with co-workers, customers, and vendors. Good computer and organizational skills. Ability to adjust work schedule if needed to meet project timelines. Qualifications Education/Experience: A 4 year college education which included Laboratory Sciences and technical training closely related to this position; or an equivalent combination of education and experience is required; or a 2 year college education leading to an Associate degree in Laboratory Sciences and/or related technical subjects and 2 years of directly related experience. A combination of formal training and experience equivalent to the above Experience in laboratory research and familiarity with Laboratory Information Systems preferred.
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