Job Description
Insight Global is looking for a Clinical Laboratory Specialist to support one our large fortune 500 Medical Device clients. This person will provide input to design, evaluation, execution and reporting for safety and efficacy of new or modified in-vitro diagnostic devices, as well as provide innovative ideas cross functionally with other business units. They will be responsible for managing clinical laboratory studies and complaint testing through a variety of clinical testing methods. The ideal candidate possesses scientific technical competence and works with human blood in clinical laboratory disciplines such as phlebotomy, chemistry, hematology, coagulation, urinalysis, point of care and capable operation of numerous instrument platforms. This position provides support from a base of clinical experience and knowledge to resolve customer complaints through clinical investigations. This position will also provide support to guide/implement innovation, product development, clinical testing, manufacturing, and post market surveillance to ensure completion of projects.
Primary Responsibilities:
* Conducts clinical testing, maintains laboratory instrumentation and inventory to strategically align with the priorities within the lab and business objectives
* Participates in development of the clinical strategy for all products and is responsible for generation of scientific and clinical information to support product conceptualization, feasibility and development
* Management of individual focused projects to complex projects involving multiple internal clinical studies/evaluations
Implements and documents Quality Assurance and Quality Control procedures as they pertain to instrumentation and methodology
Required Skills & Experience
3+ years of relative experience in clinical or hospital laboratory environment
Strong understanding of blood collection, hematology, urinalysis, coagulation, and POC (point of care) testing
BA/MA in Clinical Laboratory Science, Medical Technology, Biology Life Sciences, or other health related field
ASCP Certification (American Society of Clinical Pathology)
Nice to Have Skills & Experience
Previous work experience in hospital
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.