USA-Clinical Contract Coordinator II (Clinical)

Role Summary

• Coordinate biological specimen management for pre-clinical and clinical studies, including specimen reception, registration, storage, shipment, tracking, and inventory management at the laboratory site.
• Support end-to-end biospecimen lifecycle activities for assigned clinical studies, ensuring compliance with regulatory requirements, quality standards, and Good Laboratory and Clinical Practices (GLCP).
• Collaborate with cross-functional stakeholders including Translational Medicine Operations, Lab Sciences, Clinical Operations, Biomarker teams, Data teams, Bioanalysis Outsourcing, and external laboratories/vendors.
• Maintain laboratory operations, LIMS records (e.g., Watson), equipment, inventories, documentation, procedures, and support audits, inspections, and continuous process improvements.

Key Responsibilities

• Receive, register, store, ship, track, and dispose of biospecimens while maintaining accurate documentation and LIMS records.
• Create study designs in Watson LIMS and maintain specimen, equipment, and consumable inventories.
• Monitor specimen receipt, identify and report discrepancies, and coordinate resolution with the Biospecimen Manager.
• Maintain laboratory work areas, equipment, and documentation in compliance with GLCP and safety requirements.
• Create and update SOPs/procedures, participate in process improvements, meetings, and working groups.
• Support audits and inspections and serve as the sample process/documentation representative.
• Support biospecimen management activities for clinical studies from collection through analysis, storage, shipment, and destruction.
• Review study documentation including protocols, informed consent forms, laboratory specifications, eCRF specifications, and data collection strategies.
• Develop Biospecimen Management Plans (SMPs), collection workflows, specimen tracking reports, and maintain documentation in the eTMF.
• Coordinate with central laboratories, biorepositories, outsourcing partners, and third-party vendors while ensuring specimen traceability and chain of custody.

Required Qualifications

• Bachelor's degree in Biological Sciences, Biomedical Sciences, Biotechnology, Clinical Laboratory Science, Public Health, Life Sciences, or a related field.
• 3–6 years of experience in biospecimen management, clinical laboratory operations, or clinical trial sample management.

Required Skills

• Biospecimen lifecycle management and laboratory coordination.
• LIMS proficiency (preferably Watson) and specimen tracking systems.
• Clinical trial sample management experience.
• Knowledge of GCP, GCLP, CLIA, CAP, and ICH-GCP guidelines.
• Experience with Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) systems.
• Strong project coordination, timeline management, cross-functional communication, and English proficiency.
• Ability to support urgent sample processing and perform manual laboratory activities.

Preferred Qualifications

• Experience supporting global, multi-site clinical studies.
• Experience with biorepository or biospecimen banking operations.
• Project management experience.