Lab Technologist

Diagnostica Stago•Mount Olive, NJ

4d•Onsite

About The Position

The Lab Technologist will stay current with instrument capabilities and clinical trial regulations to provide input to clinical trial designs and execution. This role involves interacting with groups like CLSI, CLIA, and CAP to ensure the company is at the forefront of market evolution. The technologist will work closely with French counterparts to support R&D activities and clinical trials in the US for new Hematology and Hemostasis product launches. Responsibilities include developing study protocols, verifying technical conditions, ensuring instruments are in pristine working order, and maintaining equipment. The role also involves managing logistics for clinical studies, understanding protocol requirements, working with the NCRA for study follow-up, ensuring corrective actions are taken, and checking the completeness and traceability of data. The technologist will perform Linearity and Method Comparison testing using knowledge of instrument validation, interference, on-board stability, Limit of Blank, Limit of Detection, and Limit of Quantification. They will also maintain laboratory equipment, participate in new equipment validation, assist with clinical study binders and eCRF utilization, manage equipment service contracts, and complete clinical trial documentation. Scientific presentations and support for new product launches may also be required.

Requirements

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 preferably.
Experience with instrument validations, correlations and training lab staff on new laboratory instrumentation.
Must be able to travel internationally.

Nice To Haves

MT(ASCP) Certification or equivalent preferred.
Travel may be required for this position up to 10%.

Responsibilities

Stays current with instrument capabilities and clinical trial regulations to provide input to clinical trial designs and execution.
Interacts with groups such as CLSI, CLIA, and CAP to ensure the company is at the forefront of the market's evolution.
Works closely with French counterparts to conduct and support R&D activities and clinical trials in the US for new Hematology and Hemostasis product launches.
Participates in the development of study protocols and ensures study designs are appropriate for lab execution.
Verifies technical conditions prior to study starts, ensures instruments are in pristine working order, and that equipment maintenance is up to date.
Utilizes local service operations members to create good logistical conditions for clinical studies, including delivery of reagents/instruments, specimens, correspondence, contracts, and administrative documents.
Ensures full understanding of protocol requirements for efficient study progression and meeting organizational timelines.
Works closely with the NCRA for all necessary study follow-up in accordance with defined procedures.
Ensures corrective actions are followed for proper conduct to freeze databases of results in accordance with the studies initial objectives.
Checks completeness of records (paper and electronic), ensures centralization and formatting of data from studies, and ensures traceability of data.
Performs Linearity and Method Comparison testing using knowledge of instrument validation, interference, on-board stability, Limit of Blank, Limit of Detection, and Limit of Quantification.
Maintains laboratory equipment following daily, weekly, and monthly maintenance schedules, and performs required quality control for all laboratory analyzers.
Participates in validation of new equipment as appropriate.
Assists the NCRA’s in the development and maintenance of clinical study binders and utilization of eCRF.
Manages Laboratory equipment service contracts and documentary elements of clinical trial activities.
Completes necessary clinical trial documentation from the site's perspective in preparation for study start-up.
Gives scientific presentations as required.
Offers support on new product launches as needed.