LABORATORY TECHNOLOGIST

H. T. PROF Group; Hackettstown (NJ); On-site; USD 65,000 - 85,000; Full time

Job summary

H. T. PROF Group in New Jersey seeks a Laboratory Technologist with strong Hematology and Coagulation background to support clinical trials and R&D activities.

You will verify conditions, train staff on new instrumentation, and coordinate with service operations to ensure timely delivery of reagents, instruments, and samples. The role requires 5+ years experience in Hematology/Coagulation, and MT(ASCP) certification or equivalent preference.

Qualifications

• 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, instrument validations, correlations and training lab staff on new laboratory instrumentation.

Responsibilities

• The Laboratory Technologist is involved with clinical trial regulations to provide input to clinical trial designs and execution.
• Assist in conducting and supporting R&D activities and clinical trials, in development of new Hematology and Hemostasis product launches.
• Verify technical conditions prior to the start of a study and work with service operations to ensure delivery of reagents, instruments, specimens, and required documents.
• Ensure protocol requirements are understood to keep studies on schedule and maintain data integrity.
• Collaborate with the NCRA for study follow-up, ensure proper documentation, and maintain traceability of data.
• Support validation of new equipment and assist in development of clinical study binders and eCRF usage.
• Manage laboratory equipment service contracts and related documentation; prepare study startup materials.
• Present scientific information as required and support product launches as needed.

Skills

Hematology

Coagulation

Instrument validation

Education

B.S. Medical Technology/Clinical Laboratory Science

Tools

Laboratory equipment maintenance

Job description

• 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.