pulliStudy site selection, initiation (SIV) and clinical monitoring. /liliPerform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience. /liliPrepare 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. /liliEnsure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP. /liliTrack study recruitment to ensure recruitment target is achieved in all studies. /liliConduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating. /liliEnsure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study. /liliAssemble site specific EC submission dossier, and ensure submission to EC. /li /ulh3Training /h3ulliProvide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements. /liliConduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.



/li /ulh3Documentation /h3ulliEnsure 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. /liliPrepare/complete study records' archiving according to protocol and sponsor requirements. /li /ulh3(b) Drug Safety /h3ulliEnsure safety information is disseminated to all sites according SOP and applicable regulations. /liliEnsure SAE is reported within the timeline in compliance with SOPs and applicable regulations. /li /ulh3(c) Finance and Administration /h3ulliFinalize budget and obtain signed contract from site, prior to site initiation visit. /liliEnsure Study Payment Schedule is executed and retain relevant documents/receipts. /li /ulh3(d) Study Tools and system /h3ulliUpdate and maintain Study tools/systems in a timely manner. /li /ulh33. Qualifications /h3p3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. /pp3.2 At least 8 year of CRA experience; /pp3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; /pp3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc. /p /p #J-18808-Ljbffr

📌 Contractor Cra_Italy (Trieste)
🏢 Tigermed
📍 Trieste