Clinical Research Associate II

14 ott - Roma
Germany

Clinical Research Associate II / Senior Clinical Research (CRA) - ItalyJob Category: Clinical Monitoring
Requisition Number: CLINI002065
- Posted : October 1, 2026
- Full-Time
- Remote

LocationsShowing 1 location
Italy - Remote

DescriptionWhatYou'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
- AdvanceYourCareer–Weinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,.
- JoinanAward-WinningTeam–Joinaglobalteamspanning60

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