Study site selection, initiation (SIV) and clinical monitoring. Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations. Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.
Training
Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements. Finalize budget and obtain signed contract from site, prior to site initiation visit. 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc. Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.