Clinical Research Specialist role in Franklin Lakes, NJ, supporting the design, evaluation, execution, and reporting of safety/efficacy studies for in-vitro diagnostic devices. Involves hands-on clinical lab work with human blood specimens across disciplines like phlebotomy, chemistry, hematology, coagulation, and point-of-care testing. 1 opening. Onsite, 1st shift (9:00 AM- 5:00 PM). 9-panel drug screen required.
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- Conduct scientific investigations and recommend solutions within areas of considerable scope and complexity
- Adapt clinical laboratory methodologies as needed
- Conduct clinical testing and maintain lab instrumentation, reagent test systems, and inventory
- Implement and document Quality Assurance/Quality Control procedures for instrumentation and methodology
- Perform instrument verification per CLSI guidelines; support procedure updates and performance documentation (GLP/GCP compliant)
- Stay current in clinical laboratory science through literature review, continuing education, and industry engagement
- Train new associates on laboratory workflow
- Monitor lab practice trends and recommend/influence related projects
- Support clinical strategy development and generate scientific/clinical data for product conceptualization and feasibility
- Maintain scientific integrity and accuracy of product-related claims and communications
- Manage projects ranging from individual studies to complex, multi-study evaluations
- Support customer complaint resolution through clinical investigation
- Collaborate with R&D and cross-functional teams on innovation, product development, and post-market surveillance
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- 5+ years in a clinical laboratory environment
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- Clinical laboratory science (phlebotomy, chemistry, hematology, coagulation, urinalysis, point-of-care testing)
- Instrument platform operation
- GCP/GLP and ISO regulatory awareness
- Human blood specimen collection and handling
- Product troubleshooting related to clinical results
- Project planning and budget management
- New testing methodology development (in collaboration with R&D)
- Strong computer skills
- Excellent verbal and written communication