Position Summary
Working independently, you will be responsible for performing routine and special clinical laboratory testing using automated, semi-automated and/or manual methods and equipment, and coordinating and organizing assigned laboratory sections (including Hematology, Chemistry, Urinalysis, Immunoassay, Coagulation and Biomarkers). Your responsibilities will also include quality control, assisting in the validation of new assays/instrumentation, new employee training/mentoring, documentation of data collection and other experiments, serving as a back-up to instrument key operators, performing instrument calibrations, maintenance, reagent inventory and sample processing. You will serve as a back-up for pharmacokinetic biospecimen processing and sample shipping as required. KEY RESPONSIBILITIES Performs routine and special clinical chemistry, hematological, coagulation, urinalysis, immunological and other tests according to the Standard Operating Procedures. Performs all quality control checks (monitor trends) on instruments, reagents, and techniques, maintains quality control and calibration data. Maintains the inventory of and order laboratory supplies including notifying instrument key operators of upcoming reagent/supply needs. Perform data entry and monitor laboratory information system (LIS). Be flexible with the schedule to cover inadvertent times that subjects/volunteers arrive for visits, check-ins, and discharges late. Utilize PIMS, Cerner and/or electronic notebooks for processing samples. Assist the Laboratory Quality Coordinator with preparation for Internal audits and CLIA, COLA or CAP audits. May cover off hours PK sample processing as needed. Rotate though Specimen Processor functions as needed.
Minimum Qualifications
Associate's degree in Medical Technology and MLT or MT certification Minimum of 2 years of relevant laboratory work experience in a pharmaceutical, hospital, or medical research environment Hands-on experience with computers and laboratory data handling acquisition systems and knowledge of associated issues/risks Proficient with Word applications. Strong customer facing communication skills
Preferred Qualifications
Bachelor’s degree in a chemical, physical or biological science with the following educational requirements that meet CLIA 88 standards for high complexity laboratories: ---16 semester hours of biology courses, which are pertinent to medical sciences. ---16 semester hours of chemistry (at least 6 hours of Inorganic Chemistry) --- 3 semester hours of math Knowledge of pharmaceutical clinical research operations/trials or experience in a clinical trials environment. Working knowledge of GxP, GCP, CAP and CLIA regulations PHYSICAL/MENTAL REQUIREMENTS May require long period of standing. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS May require coverage during off hours in specimen processing.
