Clinical Research Associate II​/Senior Clinical Research; level dependent

Clinical Research Associate II / Senior Clinical Research (level dependent on experience)

• 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

• 3 - 5 years
  clinical research experience as a CRA or related profession
  in 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

• Advance Your Career –Weinvestinyourprofessionalgrowth.
  
  Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.
  
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• Joinan Award-Winning Team
  –Joinaglobalteamspanning
  60countries,recognizedforitsaward-winningculturethatprioritizespeople.
  
  Wesupportyourwork-lifebalancewithhybridworkopportunities.
  
  ThroughourCTICaresprogram,you’llhaveopportunitiestogivebacktoyourcommunityandtheworld.
• Makea Lasting Impact –AtCTI,yourworkdirectlycontributestoadvancingmedicine.
  
  You’llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.
  
  Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost.

• Wewillnevercommunicatewithyouvi Microsoft Teamsortextmessage
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