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Location: Hackettstown, NJ | Schedule: Full-time, on-site

Overview

A clinical diagnostics organization involved in hematology and hemostasis product development is seeking a Laboratory Technologist to support R&D activities and clinical trials. This role plays a key part in ensuring clinical studies run efficiently, from technical setup through data integrity and reporting, in support of new product launches.

What you'll do

• Provide input into clinical trial design and execution in accordance with clinical trial regulations
• Assist in conducting and supporting R&D activities and clinical trials tied to new Hematology and Hemostasis product launches
• Verify technical conditions prior to the start of a study
• Coordinate with service operations to establish logistics for clinical studies, including delivery of reagents and/or instruments, specimens, correspondence, contracts, and administrative documents
• Ensure full understanding of protocol requirements so studies proceed efficiently and meet organizational timelines
• Work closely with the NCRA on all necessary study follow-up, including checklists for site initiation and monitoring visits
• Ensure corrective actions are followed for proper conduct to freeze databases of results according to study objectives
• Check completeness of records across paper and electronic media, ensure centralization and formatting of study data, and maintain data traceability
• Apply knowledge of instrument validation, interference, on-board stability, Limit of Blank, Limit of Detection, and Limit of quantification to perform Linearity and Method Comparison testing
• Maintain laboratory equipment per daily, weekly, and monthly maintenance schedules, and perform required quality control for all laboratory analyzers
• Participate in validation of new equipment as appropriate
• Assist NCRAs in developing and maintaining clinical study binders and utilizing eCRF
• Manage laboratory equipment service contracts and documentary elements of clinical trial activities
• Complete necessary clinical trial documentation from the site's perspective in preparation for study start-up
• Give scientific presentations as required
• Offer support on new product launches as needed

Required qualifications

• B.S. Medical Technology, Clinical Laboratory Science, or equivalent from an accredited four-year college or university required
• Minimum five years experience in Hematology and Coagulation
• Experience with instrument validations, correlations, and training lab staff on new laboratory instrumentation

Preferred qualifications

• MT(ASCP) Certification or equivalent preferred
• Experience in Hematology and Coagulation preferred, along with instrument validation and correlation experience

Why this role

This position offers the opportunity to directly shape clinical trial execution and contribute to new Hematology and Hemostasis product launches, working closely with study teams from protocol design through data finalization.