Education and Experience:

- Bachelor's degree in 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, including experience with instrument validations, correlations, and training lab staff on new laboratory instrumentation.

Responsibilities:

- Provide input to clinical trial designs and execution by ensuring compliance with regulations.
- Assist in conducting and supporting R&D activities and clinical trials, particularly in the development of new Hematology and Hemostasis product launches.
- Verify technical conditions prior to the start of a study.
- Work with service operations team to create logistical conditions for clinical studies, including delivery of reagents and instruments, specimens, and exchange of documents.
- Ensure protocol requirements are understood for efficient study progress.
- Collaborate with NCRA for study follow-up according to defined procedures.
- Implement corrective actions to achieve study objectives.
- Maintain and format data from studies for traceability.
- Conduct Linearity and Method Comparison testing using knowledge of instrument validation.
- Maintain laboratory equipment and perform required quality control.
- Assist in validation of new equipment.
- Develop and maintain clinical study binders and utilize eCRF.
- Manage laboratory equipment service contracts and documentation for clinical trial activities.
- Complete necessary clinical trial documentation for study start-up.
- Give scientific presentations as needed.
- Provide support for new product launches.