Clinical Research Associate

Il y a 1 semaine

France, Auvergne-Rhône-Alpes CTI Temps plein

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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 yearsclinical research experience as a CRA or related professionin Germany incl. independent monitoring experience in Germany
Life science background
Excellent knowledge in ICH-GCP and regulatory requirement
Fluent (at least Level B2) in spoken and written English

AboutCTI

AdvanceYourCareer–Weinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals.
JoinanAward-WinningTeam–Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram,you’llhaveopportunitiestogivebacktoyourcommunityandtheworld.
MakeaLastingImpact–AtCTI,yourworkdirectlycontributestoadvancingmedicine.You’llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost.

PleaseNote

WewillnevercommunicatewithyouviaMicrosoftTeamsortextmessage
Wewillneveraskforyourbankaccountinformationatanypointduringtherecruitmentprocess

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