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 language German and 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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Clinical Research Associate II / Senior Clinical Research (CRA) (m/w/x) Germany in Ulm Arbeitgeber: CTI
Die Convention against Torture Initiative (CTI) bietet eine einzigartige Gelegenheit, in einem dynamischen und bedeutungsvollen Umfeld zu arbeiten, das sich für die weltweite Umsetzung der UN-Konvention gegen Folter einsetzt. Mit einem engagierten Team in Genf fördert CTI eine inklusive und unterstützende Arbeitskultur, die auf Zusammenarbeit und persönlichem Wachstum basiert. Mitarbeiter haben Zugang zu umfangreichen Weiterbildungsmöglichkeiten und können aktiv an der Gestaltung von Strategien zur Verbesserung der Menschenrechte teilnehmen, was diese Position besonders erfüllend macht.
