Grifols
The Clinical Research Associate assists in the management of the clinical monitoring process, ensuring site adherence to regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. They coordinate study start-up, track progress, review regulatory documents, plan meetings, conduct monitor training, perform monitoring activities, manage safety documentation, collaborate with data management, facilitate payments, and review trial-related documentation. They also evaluate vendor performance, maintain CTMS, audit study files, and assist with audit responses.