LABORATORY TECHNOLOGIST

Keystone Distinction Group; Hackettstown (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Keystone Distinction Group is seeking a Laboratory Technologist in New Jersey to support hematology and coagulation work within clinical trials. The role involves instrument validation, data management, and collaboration with the service operations team to ensure proper study logistics.

The candidate should have a B.S. in Medical Technology/Clinical Laboratory Science and MT(ASCP) certification is preferred, with at least five years of relevant experience.

Qualifications

• Bachelor's degree in Medical Technology/Clinical Laboratory Science or equivalent.
• MT(ASCP) certification preferred.
• Five+ years experience in hematology and coagulation with instrument validation experience.
• Experience training lab staff on new instrumentation.

Responsibilities

• Support clinical trial design and execution under regulatory guidelines.
• Assist in R&D and development of hematology/hemostasis products.
• Verify technical conditions before study start and coordinate logistics.
• Collaborate with service operations to ensure delivery of reagents, instruments, and samples.
• Maintain equipment with routine QC and participate in validation of new equipment.
• Prepare study binders and documentation for site initiation and monitoring.

Skills

Hematology

Coagulation

Clinical laboratory experience

Education

B.S. Medical Technology/Clinical Laboratory Science

MT(ASCP) Certification

Tools

Instrument validation procedures

Job description

Education Experience:

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

Experience:

The Laboratory Technologist is involved with clinical trial regulations in order to provide input to clinical trial designs and execution. Assist in conducting and supporting R&D activities and clinical trials, in deveopment of new Hematology and Hemostasis product launches. You will verify technical conditions prior to the start of a study. Working with members of the service operations team, create good logistical conditions for clinical studies, which include delivery of reagents and/or instrument, specimens, exchange of correspondence, contracts, and administrative documents.

Additopnal duties & requirements include:

• Ensure full understanding of the protocol requirements to ensure the study proceeds efficiently in order to meet organizational time lines.
• Work closely with the NCRA for all necessary study follow-up in accordance with defined procedure, including but not limited to the checklist for site initiation and monitoring visits, etc.
• Ensure corrective actions are followed for proper conduct to freeze databases of results in accordance with the studies initial objectives.
• Check completeness of records (all forms of media: paper and electronic), ensure centralization and formatting of data from studies, as well as ensuring traceability of data.
• Use knowledge and experience with instrument validation, interference, on-board stability, Limit of Blank, Limit of Detection, Limit of quantification to perform Linearity and Method Comparison testing.
• Maintain laboratory equipment following daily, weekly and monthly maintenance schedules as well as required quality control for all laboratory analyzers.
• Participates in validation of new equipment as appropriate.
• Assist the NCRA’s in the development and maintenance of clinical study binders and utilization of eCRF.
• Manages the Laboratory equipment service contracts and documentary elements of clinical trial activities;
• Completes necessary clinical trial documentation from the site's perspective, in preparation of study start up.
• Give scientific presentations as required.
• Offer support on new product launches as needed.