The purpose of this contract is to provide assistance in the improvement of clinical research practices.

The holder carries out the research and service provider audits on behalf of Inserm and the agency.

The French language is the language of use of audits, but they can be carried out in English on the international network.

In view of the current health crisis related to COVID-19, the incumbent may be asked to conduct remote clinical research audits and ensure adequate safety measures are in place.

The CRP and the Agency may need to change some of their practices or adapt the management of their projects following audit observations, identification of malfunctions, regulatory changes, innovative nature of projects or simply as part of their quality and continuous improvement approaches. respective.

The contract holder will be asked to assist them in defining and implementing these changes. This accompaniment can be translated by:

— carrying out regulatory analysis (notice/support);

— carrying out an impact assessment and drawing up an action plan;

— the production of documents following the consideration of changes;

— support from the working group responsible for implementing these changes;

— ad hoc support on the deployment of a new practice.

In order to clarify the needs and to define the planned schedule for completion, the CRP or Agency shall conduct a preparatory meeting with the incumbent.