Senior Clinical Lab Research Specialist - Urgent Need

About the role

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. The role requires 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.

Responsibilities

• Provide input to and conduct scientific investigations in areas of considerable scope and complexity; explore, identify and recommend solutions, concepts and principles.
• Adapt methodologies as needed for areas related to the core clinical laboratory.
• Conduct clinical testing, maintain laboratory instrumentation/reagent test systems and inventory to align with lab and business priorities.
• Implement and document Quality Assurance and Quality Control procedures for instrumentation and methodology.
• Conduct instrument verification per CLSI guidelines; assist with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP.
• Keep current in the field of Clinical Laboratory Science through technical literature review, continuing education via webinars/symposia, and customer visits.
• Train new associates (permanent or temporary) on laboratory workflow.
• Monitor trends in laboratory practices and recommend new projects or influence ongoing projects.
• Participate in development of the clinical strategy for client IDS-Specimen Management products and generate scientific and clinical information to support product conceptualization, feasibility and development.
• Ensure scientific integrity and clinical accuracy of all claims and communications concerning specific PAS products globally.
• Manage individual focused projects to complex projects involving multiple internal clinical studies/evaluations.
• Support customer complaint resolution through clinical investigations.
• Guide and implement innovation, product development, clinical testing, manufacturing, and post market surveillance via interfacing with R&D and GCD.

Requirements

• 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.

Skills

• Strong working knowledge of clinical laboratory science.
• Excellent verbal and written communications skills.
• Awareness/basic knowledge of GCP/GLP and ISO regulations.
• Phlebotomy is a plus.
• Experience with human blood specimen collection products.
• Product troubleshooting as it relates to clinical results.
• Strong computer skills.
• Strong project planning and budget management skills.
• Develop/implement new testing methodologies in collaboration with R&D.
• Proven understanding of clinical laboratory testing, blood collection, urinalysis, POC and ability to apply knowledge to innovative concepts/projects beyond the core clinical laboratory.