What are the responsibilities and job description for the Clinical Laboratory Specialist position at Amerit Consulting?
Position : Clinical Lab Scientist
Location : Franklin Lakes, NJ 07417
Duration : 12-month contract with possible extension
Pay Rate : $40 / hr - $44 / hr (depending on experience)
Relocation Expenses / Assistance : NO
Job Description :
- Work on-site in Franklin Lakes 5 days a week from 8 : 30 AM to 5 : 00 PM.
- Handle human blood within a dynamic laboratory environment.
- Contribute to the design, evaluation, execution, and reporting of safety and efficacy for innovative in-vitro diagnostic devices.
- Utilize your expertise in clinical laboratory disciplines including phlebotomy, chemistry, hematology, coagulation, urinalysis, and point of care testing, while operating various instrument platforms.
- Oversee clinical laboratory studies and perform complaint testing using diverse clinical testing methods.
- Showcase your knowledge in demonstrating the safety and effectiveness of new or modified in-vitro diagnostic devices.
- Collaborate with R&D to develop and implement new testing methodologies.
- Understand product design and function while applying quality and regulatory standards effectively.
- Perform Clinical Software Validations (CSV) for new instrument validation / qualification, ensuring best practices in IQ / OQ / PQ compliance.
- Engage with multiple disciplines (manufacturing, marketing, quality, regulatory, etc.) to support clinical laboratory operations and services.
- Conduct scientific investigations, contributing innovative ideas and solutions to complex projects.
- Adapt methodologies as necessary to maintain alignment with core laboratory goals.
- Conduct clinical testing and maintain laboratory instruments, reagents, and inventory in line with lab priorities and business objectives.
- Implement and document effective Quality Assurance and Quality Control procedures.
- Carry out instrument verification according to CLSI guidelines, and assist with updates and compliance documentation related to GLP and GCP.
- Stay informed in the field of Clinical Laboratory Science through continued education and literature reviews.
- Train new associates on laboratory workflows and procedures.
- Monitor trends in laboratory practices and recommend new initiatives to enhance operations.
- Contribute to the clinical strategy for IDS-Specimen Management products and support the generation of scientific and clinical data.
- Ensure scientific integrity and clinical accuracy of communications regarding PAS products globally.
- Manage individual and complex projects involving multiple internal clinical studies and evaluations.
- Utilize clinical expertise to resolve customer complaints through investigations.
- Support innovation, product development, clinical testing, and post-market surveillance by collaborating with R&D and GCD.
Job Requirements :
Salary : $40 - $44