Responsibilities Cualquier información adicional que necesite para este trabajo se encuentra en el texto a continuación. Asegúrese de leerla detenidamente y luego envíe su solicitud. (a) Site management • Study site selection, initiation (SIV) and clinical monitoring. • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience. • 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. • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP. • Track study recruitment to ensure recruitment target is achieved in all studies. • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating. • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs)
to the site for start-up and throughout the study. • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements. • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files. • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations. • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Admini