Contractor CRA_Italy
Pubblicato il 31-08-2026 - Tigermed in Belluno
pResponsibilities /pp(a) Site management /pp• Study site selection, initiation (SIV) and clinical monitoring. /pp• 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. /pp• 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. /pp• Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP. /pp• Track study recruitment to ensure recruitment target is achieved in all studies. /pp• Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating. /pp• Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study. /pp• Assemble site specific EC submission dossier, and ensure submission to EC. /ppTraining /pp• Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements. /pp• Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.
/ppDocumentation /pp• 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. /pp• Prepare/complete study records’ archiving according to protocol and sponsor requirements. /pp(b) Drug Safety /pp• Ensure safety information is disseminated to all sites according SOP and applicable regulations. /pp• Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. /pp(c) Finance and Administration /pp• Finalize budget and obtain signed contract from site, prior to site initiation visit. /pp• Ensure Study Payment Schedule is executed and retain relevant documents/receipts. /pp(d) Study Tools and system /pp• Update and maintain Study tools/systems in a timely manner. /p p3. Qualifications /pp3.1 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