Contributes to the selection of potential investigators.

In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulator Authorities for start-up and for the duration of the study.

Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.

Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.