Quality Auditor - Clinical Research

This is an interesting position which involves ensuring overall Quality in a Clinical Research Organisation (CRO) environment. It is a role which involves a lot of travel to various Client and supplier sites. A keen eye for detail and skill in dealing with people in required.

Main Responsibilities

• Conducting investigator site and CRO audits
• Carrying out the Audit of internal GCP tasks and departments
• The maintenance of the audit log and global audit plan
• Act as the sole Clinical QA representative on study teams that are assigned to your control
• Performing Study document compliance audits
• Provide GCP training to colleagues

Skills/Experience

• A degree in health sciences, nursing, pharmacy or related field
• Extensive experience in carrying out GCP audits in the EU inline with FDA/EMEA/global regulatory requirements and to GCP guidelines
• A willingness to travel up to 50% of the time