Details: Client is seeking Clinical Quality Assurance Auditor in Exton, PA. This is a 6 month renewable contract role. 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 conducted. In addition, the incumbent shall support the development; revision of GCP related SOPs as well as provides support for BLA preparations and the development and implementation of the Inspection Awareness/Readiness program. Oncology Experience Required. Responsibilities Include: Provide support for the development and implementation of the Inspection Awareness/Readiness Program Support the development and revision of GCP related SOPs Reviews audit responses for acceptability; elevates issues that are above incumbents abilities or that cannot be resolved Recommends corrective action to compliance issues and/or observations as needed to insure corrective action is implemented Monitors clinical operations corrective action process to insure corrective actions are being applied Other projects and responsibilities may be added at the company discretion
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