Quality Assurance Auditor

Quality Assurance Auditor

Scope of Services

The prospective company will provide Quality Assurance Audits for all Clinical Trials sponsored by University Hospitals of Leicester NHS Trust, Including but not limited to Trial Master File/ Investigator Site File, Source data/CRF , Pharmacy, Laboratory, Data Systems and review of External Vendors where applicable.

The Audit shall be undertaken in accordance with Sponsor SOPs, all applicable laws, regulations and guidelines relating to Clinical Trials.

The Service will include Audit of both local and national sites and hence the Auditor will sometimes be required to travelling long distances and may have to consider overnight stay. The Trust expects a minimum of 24 Audits conducted per annum each comprising of 1 day = 7.5 working hours excluding travel.

The assignment and co-ordination of Audit visits will be undertaken by the Trust's Research & Innovation Monitoring Team. A full report and associated Corrective Action Preventative Action(CAPA) is expected to be delivered within 10 working days of completing the Audit visit.

All expressions of interest and tender responses must be made by way of the Trust's e-tendering Portal, Procontract. All tenders submitted outside that process will be rejected. The tender documentation can be found at the following link:

http://www.supplying2nhs.org/

All suppliers will need to register prior to accessing the documentation, which is free to register.

To register click on the suppliers area and the registration link is on the top right of the next page