Laboratory Sample Coordinator in Arlington, Massachusetts

Clinical Contract Coordinator II

Location:

Cambridge, MA

Contract:

12+ months - possible extension - based on performance and business

The Clinical Contract Coordinator (CCC)'s primary mission will involve organizing the biological specimen management laboratory, reception, registration, storage, and shipment of biospecimen for pre-clinical and clinical studies received at a Laboratory Site. The CCC will be secondarily assigned to clinical studies and may be responsible for the collection, processing, storage, and distribution of biological specimens in support of clinical research and development programs.

This role ensures compliance with regulatory requirements, quality standards, and ethical guidelines while managing biospecimen operations across multiple studies and sites.

As a CCC you will be directly reporting to the Global head of the Translational medicine operations BSM department or a delegated team lead and will collaborate closely with the global translational medicine operations biospecimen management team in addition to other stakeholders such as local site head of lab sciences, scientists, Precision/Biomarker/PK/ADA leads, clinical operations study/project leads, Data leads, Biomarkers & Bioanalysis outsourcing team.

You will be responsible for the day-to-day coordination and management of laboratory sample operations, ensuring accurate receipt, processing, storage, and tracking of biological specimen.

• Receive, record, store, dispose, and ship Bio Specimen addressed to the laboratory from across global locations and verify the compliance of the related delivery documentation.
• Ensure and perform the registration of pre-clinical/clinical study Bio Specimen received in our LIMS (Laboratory Information Management System e.g. Watson) and generate and send documents related to these receptions.
• Manage the recording of receptions and shipments in dedicated tracking files.
• You detect, analyze, and report inconsistencies during Bio Specimen reception and registration to the study Bio Specimen Manager who will support you in resolving these inconsistencies.
• Ensure the creation of study designs in Watson LIMS.
• Ensure the maintenance of the BSM laboratory work areas and proper functioning of equipment.
• Ensure work quality in accordance with Good Laboratory and Clinical Practices (GLCP).
• Monitor regular equipment maintenance and update established documentation.
• Ensure and perform registration and update of inventories (Bio Specimen, equipment, and consumables).
• Continuously participate in improving the department's operations and ensure that safety instructions are followed as the Health Safety Environment (HSE) correspondent for BSM.
• Create and/or update BSM procedures.
• Participate in meetings and working groups, propose technical, organizational, and documentary improvements (procedures), and participate in process optimizations.
• Support audits and inspections; act as spokesperson for sample-related processes and documentation.

As a CCC you may be assigned perform the Bio Specimen management tasks, monitor clinical studies and oversee end-to-end biospecimen lifecycle from collection through analysis and archival.

• 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 such as the protocol, Informed Consent Form, central laboratory specifications, electronic Case Report Form (eCRF) Specifications, Data collection strategy, etc.
• Lead the design and optimization of biospecimen collection protocols and workflows
• Create the Bio Specimen Management Plan (SMP) containing instructions for collection, storage, and shipping of Bio Specimen
• Manage relationships with the Bioanalysis outsourcing, central laboratories, biorepositories, and third-party vendors as needed.
• Ensure proper chain of custody, tracking, and inventory management of all biospecimens
• Create reports…