Clinical Contract Coordinator II - Biospecimen Management | LIMS | Clinical Trials

Overview Job Title- Clinical Contract Coordinator II Location: Cambridge, MA 02141 Duration: Contract till July 2027 with possibility to extend Responsibilities Organize the biological specimen management laboratory, including reception, registration, storage, and shipment of biospecimens for pre-clinical and clinical studies received at a Laboratory Site. Coordinate clinical studies and may be responsible for the collection, processing, storage, and distribution of biological specimens in support of clinical research and development programs. Report to the Global head of Translational Medicine Operations BSM or a delegated team lead; collaborate with the global biospecimen management team and other stakeholders (site heads, scientists, study leads, data leads, and outsourcing teams). Manage day-to-day laboratory sample operations, ensuring accurate receipt, processing, storage, and tracking of biological specimens. Receive, record, store, dispose of, and ship biospecimens from across global locations; verify related delivery documentation. Register biospecimens in LIMS (e.g., Watson) and generate/send documents related to recepti ons; record receptions and shipments in dedicated tracking files. Identify, analyze, and report inconsistencies during biospecimen reception and registration; collaborate with the study BioSpecimen Manager to resolve issues. Ensure creation of study designs in Watson LIMS and maintenance of BSM lab areas; ensure proper functioning of equipment and quality of work per GLP/GCP. Monitor equipment maintenance and maintain documentation; register and update inventories (biospecimens, equipment, consumables); participate in process improvements and safety (HSE) initiatives. Create or update BSM procedures; participate in meetings and working groups; propose technical, organizational, and documentary improvements; contribute to process optimization. Support audits and inspections; act as spokesperson for sample-related processes and documentation. Global Biospecimen Management Responsibilities Potentially perform biospecimen management tasks, monitor clinical studies, and oversee end-to-end biospecimen lifecycle from collection through analysis and archiving. Implement Translational Medicine and biospecimen management strategies aligned with clinical development objectives. Partner with clinical study teams to integrate biospecimen requirements into study protocols; collaborate with translational medicine and biomarker teams on biospecimen utilization. Review study documents (protocol, informed consent form, central laboratory specs, eCRF specifications, data collection strategy, etc.). Lead design and optimization of biospecimen collection protocols and workflows; create the BioSpecimen Management Plan (SMP) with instructions for collection, storage, and shipping of biospecimens. Manage relationships with Bioanalysis outsourcing, central laboratories, biorepositories, and third-party vendors as needed; ensure proper chain of custody, tracking, and inventory for biospecimens. Create reports on biospecimen statuses and monitor biospecimens from collection to destruction; ensure traceability of documentation in the electronic Trial Master File (eTMF). Education and Experience Education: Bachelor’s degree required in Biological Sciences, Biomedical Sciences, Biotechnology, Clinical Laboratory Science, Public Health and Life Sciences or related field. Experience: 3-6 years’ experience in biospecimen management, clinical laboratory operations managing biospecimens in clinical trials or research settings. Skills and Qualifications Biospecimen Management & Lab Coordination: end-to-end workflow coordination, timeline planning and milestone tracking; strong biospecimen lifecycle expertise; clinical trial systems & tools experience; LIMS (e.g., Watson) proficiency; cross-functional coordination skills. Regulatory knowledge: GCP, GCLP, CLIA, CAP; quality standards in laboratory and clinical settings. Technical proficiency: Proficiency with LIMS and specimen tracking platforms; familiarity with clinical trial management and EDC systems. Communication and collaboration: strong written and spoken English; ability to work with global, multi-site teams. Preferred: experience with biospecimen banking or biorepository operations. #J-18808-Ljbffr Aequor