Title: Clinical Lab Coordinator II
Duration: 12 Months Possible Extension
Location: Cambridge, MA

Manager Notes:

• Day to duties of the role, lab coordinator lab management, receiving clinical samples, entering in LIMS systems Take care freezers, related documentations for samples
• Work with sample managers, support, clinical trials, data flows, sample related documents
• No cold rooms, no extreme heat No chemicals, will work with biohazards
• No heavy lifting
• Must have skills: Strong Watson, LIMS experience, similar experience
• Sample coordination experience, sample receiving any sample related work, bios specific with clinical trials.
• Biospecimen and lab operations expertise with end-to-end lifecycle management, workflow coordination, timeline planning, and strong cross-functional collaboration.
• Experience supporting clinical trials, including sample management and use of LIMS (e.g., Watson) and specimen tracking systems.
• Solid knowledge of regulatory and quality standards, including GCP, GCLP, CLIA, CAP, and ICH-GCP guideline

Description:

• 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.

LOCAL SITE LABORATORY MANAGEMENT RESPONSIBILITIE

• 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.

You will

• 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
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

SKILLS
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