Spec 3, Clinical Research

KAYGEN•Franklin Lakes, NJ

3d•Onsite

About The Position

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. Develop/implement 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.

Requirements

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.
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.

Nice To Haves

Phlebotomy

Responsibilities

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 BD 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.
This position provides support from a base of clinical experience and knowledge to resolve customer complaints through clinical investigations.
This position will also provide 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.