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Clinical Laboratory Information System Specialist

2 months ago


Exton, Pennsylvania, United States Frontage Laboratories Full time
Job Description

Job Title: Clinical Laboratory Information System Specialist

Job Summary:

Frontage Laboratories is seeking a highly skilled Clinical Laboratory Information System Specialist to join our team. As a Clinical Laboratory Information System Specialist, you will be responsible for implementing and maintaining the Central Laboratory Information System, instrument middleware, and other supporting software systems for Central Lab Services.

Key Responsibilities:

  • Database Management: Build and maintain the LIS/LIMS database for clinical trial and medical diagnostic testing and Biorepository.
  • Change Control: Assist laboratory management and QA Specialist with comprehensive Change Control related to the Laboratory Information Systems.
  • Collaboration: Liaise between laboratory management, QA, and Information Technology departments, coordinating multidisciplinary efforts.
  • Test Development: Partner with Study Setup and Project Management to build appropriate tests and calculations.
  • Procedure Development: Working with Senior System Administrator to develop and maintain Central Lab Service procedures regarding LIS/LIMS, middleware, and other supporting software systems.
  • Compliance: Ensure HIPAA and GDPR compliance in Central Lab Services processes in conjunction with QA and laboratory management.

Requirements:

  • Education: B.A/B.S. in Biology, chemistry, or related scientific disciplines with experience in a clinical laboratory setting.
  • Experience: Minimum of 1 year's experience in test build.
  • Technical Skills: Experience with LabVantage.
  • Clinical Laboratory Experience: Experience in performing or assisting clinical laboratory testing.
  • Regulatory Knowledge: Working knowledge of FDA GCP, CLIA Regulations, HIPAA, CAP checklists are highly desirable.
  • Soft Skills: High level of accountability with self and others, hands-on approach with a desire to teach others, track record of challenging the status quo, team and action-oriented, problem-solving, priority setting, timely decisions.

Equal Opportunity Employer: Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.