Quality Assurance Coordinator

Our client is a leading pharmacology business providing clinical trials / medical research for global clients.  Based in brand new facilities, you will be working in a busy, sociable and friendly open-plan environment.

Main responsibilities include:

Assist in regulatory inspections and sponsor audits

• Allocate relevant staff for meeting with auditors/inspectors according to agenda
• Ensure all study documentation is up to date and readily available by liaising with the relevant teams
• Book meeting rooms and ensure catering and computer access is made available
• Host the inspection/auditor
• Issue the audit/inspection findings to appropriate departments and submit corrective and preventative actions to auditors/inspectors

Participate in internal audits and vendor qualification

-    Coordinate internal QA systems and processes to ensure high quality data is obtained for each study

-    Liaise with Project Management to ensure vendor qualification of all new subcontractors

Ensure Good Clinical Practice training is completed by all staff

• Act as coordinator between training provider and staff for training
• Ensure completed certificate of training for all staff have been saved appropriately.

Standard Operating Procedure (SOP) Management

• Notify the relevant heads of departments when SOP revisions become due
• Ensure revision is completed in time and signed off by the relevant Director

Oversee the Incident reporting system

• Issue the incident report to relevant staff member and Head of department
• Sign off the completed report, scan and file
• Ensure the corrective and preventative actions are followed up
• Compile monthly trend analysis