Clinical Trial Information Systems Specialist

3 weeks ago


Exton, Pennsylvania, United States Frontage Laboratories Full time

At Frontage Laboratories, we are seeking a skilled Clinical Trial Information Systems Specialist to join our team in Exton, PA. This full-time, on-site position offers a competitive salary and benefits package, including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

The estimated salary for this role is $80,000 - $100,000 per year, based on industry standards and the location of Exton, PA.

Job Description:

We are looking for an experienced professional to implement and maintain our Central Laboratory Information System, instrument middleware, and other supporting software systems for Central Lab Services. As a key member of our team, you will be responsible for building and maintaining LIS/LIMS databases for clinical trial and medical diagnostic testing and Biorepository.

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

Requirements:

To succeed in this role, you should have a B.A/B.S. in Biology, chemistry, or related scientific disciplines, with experience in a clinical laboratory setting. A minimum of 1 year's experience in test build is also required. Familiarity with LabVantage and working knowledge of FDA GCP, CLIA Regulations, HIPAA, CAP checklists are highly desirable.



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