Kaygen, Inc. ยท 2 months ago
Spec 3, Clinical Research/ Clinical Lab Specialist (Pipeline)
Franklin Lakes, NJ
Full-time
Onsite
Senior Level
5+ years expKAYGEN is an emerging leader in providing top talent for technology-based staffing services. They are seeking a Clinical Lab Specialist to manage clinical laboratory studies, conduct testing, and ensure compliance with quality and regulatory standards while providing innovative solutions in the development of in-vitro diagnostic devices.
AnalyticsBig DataData ManagementInformation ServicesInformation TechnologyStaffing Agency
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
Performs Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab
Keeps current in the field of Clinical Laboratory Science through review of technical literature, and 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 Client 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
Qualification
Required
Strong working knowledge of clinical laboratory science
Excellent verbal and written communication skills
Awareness/basic knowledge of GCP/GLP and ISO regulations
Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab
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 LIS/LIMS systems 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
Benefits
Free Healthcare Insurance
Vision and Dental Insurance
401(k) Retirement Plan
Free Life Insurance
Sick Time Off
Certifications
Mentorship Program
Referrals
Family and Wellness benefits
Continuous Growth and Career Development
Company
Kaygen, Inc.
Kaygen, an award-winning technology consulting and talent firm, assists organizations to achieve digital transformation.
51-200 employees
H1B Sponsorship
Kaygen, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (2)
2022 (3)
2021 (8)
2020 (16)
Funding
Current Stage
Growth StageLeadership Team
Anshul Chaturvedi
Founder & CEO
Rashmi Chaturvedi
Co-founder & President
Company data provided by crunchbase