LAB TECHNOLOGIST SUPERVISOR

Clinical Laboratory Scientist

Education and/or 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.

Essential Duties and Responsibilities:

• Stays current with instrument capabilities and clinical trial regulations in order to provide input to clinical trial designs and execution.
• Interacts with groups, such as, but not limited to CLSI, CLIA and CAP in order to ensure Stago is at the forefront of the market's evolution.
• Works closely with counterparts to help conduct and support R&D activities as well as clinical trials in the US in facilitation of new Hematology and Hemostasis product launches.
• Participates in the development of study protocols and ensures study designs are appropriate for execution in the lab.
• Verify technical conditions prior to the start of a study, ensure instruments are in pristine working order and maintenance of equipment is up to date to ensure successful study conditions.
• Utilizing local members of the service operations, create good logistical conditions for clinical studies to include but are not limited to delivery of reagents and/or instrument, specimens, exchange of correspondence, contracts and administrative documents.
• Ensures full understanding of the protocol requirements to ensure the study proceeds efficiently in order to meet organizational time lines.
• Works 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), ensures centralization and formatting of data from studies, as well as ensuring traceability of data.
• Uses 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.
• Assists 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.
• Travel may be required for this position up to 10%, must be able to travel internationally.