Clinical Research Specialist

2 weeks ago


Franklin Lakes, United States ALOIS Solutions Full time

Base pay range $55/hr - $60/hr Title: Clinical Research Specialist Duration: 12+ months Contract (Possibility of extension or conversion) Location: Franklin Lakes, NJ 07417 Job Summary This laboratory-based position 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. Possess a 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. Responsible for managing clinical laboratory studies and complaint testing through a variety of clinical testing methods. Knowledge and expertise demonstrating safety and efficacy of new or modified in-vitro diagnostic devices, as well provide innovative ideas outside of the core business. Capable of performing Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab. Education and Experience BS/BA/MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences or health related field required. MT/MLT CLS (ASCP) or equivalent experience in a Research environment 5 years+ experience in the Clinical Laboratory environment. Primary Duties, Responsibilities & Authorities Conducts clinical testing, maintains laboratory instrumentation/reagent test systems and inventory to strategically align with the priorities within the lab and business objectives. Implements and documents Quality Assurance and Quality Control procedures as they pertain to instrumentation and methodology. Conducts instrument verification per CLSI guidelines, assists with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP. Performs Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab. Seniority level Mid-Senior level Employment type Contract Job Function Research, Analyst, and Quality Assurance Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Biotechnology Research #J-18808-Ljbffr



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