Clinical (GCP) Quality Auditor Job in West Chester 19380, Pennsylvania US

The Judge Group is currently recruiting for a dynamic, growing biopharmaceutical client in the West Chester, PA area. Opportunity for a long term contract role (1 year plus) with an oncology focused firm. Must reside locally in PA and be able to work on site. Limited travel! For immediate consideration please email your resume as a Word document to mkk@judge.com Current experience with GCP audits and inspection readiness / pre-inspection is a must.

In this position the incumbent shall support GCP audits of Phase I - III domestic and international clinical research trials to assure compliance with all applicable government regulations, federal guidelines, company standard operating procedures, and industry standards. Audits will be performed on external investigator sites, vendors/CROs, trial master files (TMFs), data/CRFs, and study reports for clinical trials. In addition, the incumbent shall support the development; revision of GCP related SOPs as well as provides support for regulatory submissions and the development and implementation of the Inspection Readiness program.  Travel estimated at 5-10%

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