Clinical Research Associate (level dependent on experience)

CTI; France; Sur place; EUR 52 000 - 80 000; Plein temps

Résumé du poste

CTI is seeking a Clinical Research professional to serve as the main contact for assigned study sites and to conduct site visits across pre-study, initiation, interim monitoring, and close-out phases in compliance with ICH GCP. You will support start-up activities, site selection, and regulatory document handling while maintaining timelines.

The role requires 3–5 years of CRA experience, including independent monitoring in Germany, a life science background, and fluent English (B2).

Qualifications

• 3–5 years clinical research experience as a CRA or related role, including independent monitoring in Germany.
• Life science background.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Fluent English (minimum Level B2) in speaking and writing.

Responsabilités

• Serve as main CTI contact for assigned study sites and manage monitoring visits.
• Conduct PSV, SIV, IMV, and COV with quality and timelines per Monitoring Plan.
• Assist with or oversee start-up activities, feasibility, and site selection.
• Collect, review and track essential regulatory documents.
• Perform site management activities and report site status to the Clinical Project Manager.
• Conduct remote monitoring per Monitoring Plan.
• Utilize systems and reports to track subject status, SDV, and IP.
• Participate in project team meetings and contribute to activities.

Connaissances

Clinical research experience

Independent monitoring in Germany

Life science background

ICH-GCP knowledge

Fluent English

Formation

Life sciences degree

Description du poste

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