Clinical Contract Coordinator II

Job Description

Job Summary:

• 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 Client 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.

Duties and Responsibilities:

• 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 Biospecimen Management Plan (SMP) containing instructions for collection, storage, and shipping of Biospecimen.
• 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 containing Biospecimen statuses and perform overall monitoring of these Biospecimen, from collection to destruction.
• Ensure the traceability of associated documentation in the electronic Trial Master File (eTMF).

Education and Experience:

• 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.

Knowledge, Skills, and Abilities:

• 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.
• Knowledge of ICH-GCP guidelines and regulatory requirements.
• 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.