Contractor CRA_Italy
Pubblicato il 31-08-2026 - Tigermed in Roma
Responsibilities
Dato l'elevato interesse per questa posizione, la preghiamo di candidarsi tempestivamente se il suo profilo è in linea con il ruolo.
(a) Site management
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Study site selection, initiation (SIV) and clinical monitoring.
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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.
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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.
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Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.
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Track study recruitment to ensure recruitment target is achieved in all studies.
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Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.
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Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.
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Assemble site specific EC submission dossier, and ensure submission to EC.
Training
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Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.
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Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.
Documentation
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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.
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Prepare/complete study records' archiving according to protocol and sponsor requirements.
(b) Drug Safety
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Ensure safety information is disseminated to all sites according SOP and applicable regulations.
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Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.
(c) Finance and Administration
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Finalize budget and o