Perform non-routine and highly specialized laboratory testing in support of investigational, feasibility, research studies and/or clinical trials to evaluate novel applications of established biomarkers and their potential use in monitoring and predicting risk of cardiovascular diseases.
Support general operations, procedure/protocol documentation, ad-hoc testing and projects, equipment operation, maintenance, troubleshooting, problem solving and supervisory responsibilities.
Utilize CLIA (42 CFR Part 493) and other operating clinical laboratory chemistry platforms
Perform test method verification, correlation, validation studies and analyze data using statistical software
Actively utilize Laboratory Information Management Systems (LIMS), and Electronic Medical Records (EMR) systems
Maintain MLS certification and working knowledge of regulatory standards (e.g. CAP/CLIA, ISO, CGP, GLP, GDP)
Performs moderate and high-complexity testing, QA/QC activities and assay validation per established protocols in support of industry-supported pre-clinical studies, investigator initiated clinical trials and feasibility work.
Analyze and document data, make detailed observations and prepare reports
Board-certified MLS (e.g. ASCP(BOR) or equivalent)
An Associate degree in biological science, at minimum
3-5 years’ experience working within a research setting, at minimum