* Serve as main CTI contact for assigned study sites * Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP * Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection * Collect, review and track essential/regulatory documents * Participate in and complete all general and study specific training as required * Participate in investigator, client and project team meetings; may include presentations * Create and implement subject enrollment strategies for assigned study sites * Ensure proper storage, dispensation and accountability of all Investigational Product (IP)
and trial-related materials * Perform site management activities and provide ongoing updates of site status to Clinical Project Manager * Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan * Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP * Assist with project-specific activities as member of Project Team What You'll Do: * Serve as main CTI contact for assigned study sites * Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP * Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection * Collect, review and track essential/regulatory documents * Participate in and complete all general and study specific training as required * Participate in investigator, client and project team meetings; may in
📌 Clinical Research Associate II (Torino)
🏢 Cti Clinical Trial And Consulting Services
📍 Torino
Candidati a questo annuncio
Mostra le tue capacità professionali all'azienda, compila il form e lascia un tocco personale nella lettera di presentazione, aiuterà il recruiter nella scelta del candidato.