Laboratory Technologist

Laboratory Technologist

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 development 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.

Additional 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.