Clinical Laboratory Research Specialist - Req 5Yrs Exp in Clinical Laboratory (Onsite)

About the role

Position: Clinical Laboratory Research Specialist; Location: Franklin Lakes, NJ; Duration: 12 Months; Hours/week: 40.00; Shift: 1st Shift; Client: Medical Devices Company; Job Category: Clinical; Employment Type: Contract on W2 (US Citizens or GC Holders or GC EAD or OPT or EAD or CPT); Onsite; 9 panel drug test required.

Responsibilities

• Provides input to design, evaluation, execution and reporting for safety and efficacy of new or modified in‑vitro diagnostic devices.
• Provides innovative ideas cross‑functionally with other business units.
• Possesses 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.
• Manages clinical laboratory studies and complaint testing through a variety of clinical testing methods.
• Demonstrates knowledge and expertise demonstrating safety and efficacy of new or modified in‑vitro diagnostic devices, as well provides innovative ideas outside of the core business.
• Develops/implements new testing methodologies in collaboration with R&D.
• Responsible for understanding product design, function and able to apply quality and regulatory standards.
• Utilizes technical/scientific judgment to resolve technical issues.
• Works with many different disciplines (manufacturing, marketing, quality, regulatory, etc.), materials, products and processes in the development of core clinical laboratory and outside the core clinical laboratory products and services.
• Possesses a strong commitment to quality and continuous improvement.
• Provides input to and conducts scientific investigations in areas of considerable scope and complexity.
• Explores, identifies and recommends solution, concepts and principles.
• Adapts methodologies as needed for areas related to the core clinical laboratory.
• 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.
• Keeps current in the field of Clinical Laboratory Science through review of technical literature, participation in continuing education via webinars/symposia and or customer visits.
• Trains new associates (permanent or temporary) on the Laboratory workflow.
• Senses and monitors trends in laboratory practices and utilizes this information to recommend new projects and influence ongoing projects.
• Participates in development of the clinical strategy for all client IDS‑Specimen Management products and is responsible for generation of scientific and clinical information to support product conceptualization, feasibility and development.
• Responsible for scientific integrity and clinical accuracy of all claims and communications made concerning specific PAS products globally.
• Responsible for management of individual focused projects to complex projects involving multiple internal clinical studies/evaluations.
• Provides support from a base of clinical experience and knowledge to resolve customer complaints through clinical investigations.
• Provides support to guide and implement innovation, product development, clinical testing, manufacturing, and post market surveillance via interfacing with R&D and GCD to insure successful and timely completion of projects.

Requirements

• BS/BA/MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences or health related field required.
• 5+ years experience in the Clinical Laboratory environment.

Qualifications

• MT/MLT CLS (ASCP) or equivalent experience in a Research 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 trouble shooting 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 an ability to apply knowledge to innovative concepts/projects beyond the core clinical laboratory.

Pay

Pay rate: $60 per hour.

Schedule