Website Berman Larson Kane
Best Staffing Options since 1980
Job Details Description
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 client is at the forefront of the market’s evolution.
- Works closely with overseas 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 timelines.
- 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.
- 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.
- Exhibits knowledge of GLP and GCP guidelines.
- 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.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.