15 ott - Roma
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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 years clinical 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,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel. Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals. JoinanAward-WinningTeam Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople. Wesupportyourwork-lifebalancewithhybridworkopportunities. ThroughourCTICaresp
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