Clinical Contract Coordinator II

We are looking for Clinical Contract Coordinator II for our client in Cambridge, MA

Job Title: Clinical Contract Coordinator II

Job Location: Cambridge, MA

Job Type: Contract

Job Overview:

Pay Range: $37.81hr - $42.81hr

Requirement/Must Have:

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

Responsibilities:

• Organize the biological specimen management laboratory, including the reception, registration, storage, and shipment of biospecimens.
• Ensure compliance with regulatory requirements, quality standards, and ethical guidelines while managing biospecimen operations across multiple studies and sites.
• Coordinate and manage laboratory sample operations, ensuring accurate receipt, processing, storage, and tracking of biological specimens.
• Receive, record, store, dispose of, and ship biospecimens addressed to the laboratory from across global locations and verify the compliance of the related delivery documentation.
• Perform the registration of pre-clinical/clinical study biospecimens received in 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.
• Detect, analyze, and report inconsistencies during biospecimen reception and registration.
• Ensure the creation of study designs in Watson LIMS.
• Ensure the maintenance of the laboratory work areas and proper functioning of equipment.
• Monitor regular equipment maintenance and update established documentation.
• Ensure and perform registration and update of inventories (biospecimen, equipment, and consumables).
• Continuously participate in improving the department's operations and ensure that safety instructions are followed.
• Create and/or update procedures.
• Participate in meetings and working groups, propose technical, organizational, and documentary improvements, and participate in process optimizations.
• Support audits and inspections; act as spokesperson for sample-related processes and documentation.
• 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 biospecimens.
• 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 biospecimens, from collection to destruction.
• Ensure the traceability of associated documentation in the electronic Trial Master File (eTMF).

Skills:

• Biospecimen management and lab coordination expertise.
• Strong biospecimen lifecycle expertise.
• Clinical trial systems and tools experience.
• LIMS (e.g., Watson) proficiency.
• Excellent cross-functional coordination skills.
• Knowledge of regulatory requirements (Google Cloud Platform, 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-Google Cloud Platform guidelines and regulatory requirements.
• Familiarity with clinical trial management and electronic data capture (EDC) systems.
• Flexibility to support urgent sample processing needs.
• Strong communication and team management capabilities.