Clinical Research Associate II

Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study. Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conducting the clinical study throughout the study period. Trains investigational site staff as necessary. When applicable, supports preparation of regulatory and / or EC submissions. Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.