USA - Clinical Contract Coordinator II (Clinical) (contract)

About the role

The Clinical Contract Coordinator (CCC)’s primary mission involves organizing the biological specimen management laboratory, reception, registration, storage, and shipment of biospecimen for pre-clinical and clinical studies received at a Sanofi Laboratory Site. The CCC will also 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.

Responsibilities

• Receive, record, store, dispose, and ship BioSpecimen 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 BioSpecimen received in our LIMS (e.g. Watson) and generate and send documents related to these receptions.
• Manage the recording of receptions and shipments in dedicated tracking files.
• Detect, analyze, and report inconsistencies during BioSpecimen reception and registration to the study BioSpecimen Manager who will support you in resolving these inconsistencies.
• Create and/or update BSM procedures.
• Implement Translational medicine and biospecimen management strategies aligned with clinical development objectives.
• 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.

Requirements

• Bachelor’s degree required in Biological Sciences, Biomedical Sciences, Biotechnology, Clinical Laboratory Science, Public Health and Life Sciences or related field.
• 3-6 years’ experience in biospecimen management, clinical laboratory operations managing biospecimens in clinical trials or research settings.

Qualifications

• Biospecimen Management & Lab Coordination requires end-to-end workflow coordination, timeline planning and milestone tracking, strong biospecimen lifecycle expertise, clinical trial systems & tools experience, LIMS (e.g. Watson) proficiency, and excellent cross-functional coordination skills.
• Knowledge of regulatory requirements (GCP, GCLP, CLIA, CAP) and quality standards.
• Proficiency with Laboratory Information Management Systems (LIMS) and specimen tracking platforms.
• Experience with clinical trial sample management.
• Familiarity with Clinical trial management & electronic data capture (EDC) systems.
• May require flexibility to support urgent sample processing needs & Manual dexterity.
• Strong communication, team management capabilities and fluency in English.
• Experience with global, multi-site clinical studies preferred.
• Experience with biospecimen banking or biorepository operations preferred.
• Project management experience preferred.