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 (level dependent on experience) employer: CTI
CTI is an exceptional employer that offers a dynamic work environment for Media Engineers passionate about broadcast and media technology. With opportunities to work on high-profile projects across the UK and Europe, employees benefit from a collaborative culture, ongoing professional development, and the chance to influence innovative solutions from concept to completion. Join a supportive team where your expertise will be valued and your career can thrive in a fast-paced industry.
