Clinical Research Associate II

1 settimana fa

Alto, Piemonte, Italia Germany Tempo pieno
Clinical Research Associate II / Senior Clinical Research (CRA)
- Italy Job Category: Clinical Monitoring Requisition Number: CLINI002065
* Posted : October 1, 2026
* Full-Time
* Remote Locations Showing 1 location Italy
- Remote Description WhatYou'llDo:
* 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 WhatYou'llBring:
* 3
- 5 yearsclinical research experience as a CRA or related profession
* Life science background
* Excellent knowledge in ICH-GCP and regulatory requirement
* Fluent (at least Level B2) in spoken and written language
- English AboutCTI
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