Clinical Research Associate

vor 1 Woche


Berlin, Deutschland Meet Life Sciences Vollzeit

Freelance Clinical Research Associate (CRA) - Germany | Early Phase Oncology StudyInterviews Taking Place This WeekLocation: Germany-based, remote with on-site monitoring visits across Germany Work Type: Freelance / Contract FTE: 0.5 FTE - approximately 20 hours/week Rate: Up to €90/hour (negotiable) Industry: Global CRO supporting Biotech Start: ASAPWe are supporting a global CRO as they expand their team on a long-term early phase oncology program (Phase I/Ib–II) running across multiple sites in Germany. This is an excellent opportunity for an independent CRA who wants stable, part-time freelance work combining classic monitoring with full responsibility for CTIS submissions.The role is fully home-based with travel to sites for initiation, routine monitoring, and close-out visits.Key Responsibilities:Oversee site start-up activities including feasibility, full regulatory & ethics submissions through CTIS (Part 1 and Part 2), and site activationPerform pre-study/site qualification visits, site initiation visits (SIV), routine monitoring visits (RMV), and close-out visitsManage essential documents and ensure ongoing regulatory complianceAct as the primary CRA contact for German investigational sitesEnsure protocol adherence and ICH-GCP standards are maintainedCollaborate closely with project management, regulatory affairs, and the wider study teamWhat We’re Looking For:Minimum 3–5 years of independent CRA experience in GermanyProven hands-on experience preparing and submitting Initial Applications and Substantial Modifications via CTIS (Part 1 & Part 2) under EU-CTR 536/2014Strong background in site start-up and monitoring (early phase oncology experience is a strong plus)Native or fully fluent GermanCurrently based in Germany with ability and willingness to travel for site visitsPrevious CRO experience strongly preferredProactive, reliable, and comfortable working autonomouslyStudy Scope:Early phase (Phase I/Ib–II) oncology studiesFlexible 0.5 FTE workload (approximately 20 hours/week)If you’re an experienced German CRA with solid CTIS expertise and are looking for a part-time freelance role in early phase oncology, we’d love to hear from you.Please send your updated CV directly here or contact me on LinkedIn / email if you're interested. Kos.hatsimeletiou@meetlifesciences.com



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