Freelance Clinical Research Associate (CRA) - Germany | Early Phase Oncology Study
Interviews Taking Place This Week!
Location: 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: ASAP
We 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 activation
* Perform pre-study/site qualification visits, site initiation visits (SIV), routine monitoring visits (RMV), and close-out visits
* Manage essential documents and ensure ongoing regulatory compliance
* Act as the primary CRA contact for German investigational sites
* Ensure protocol adherence and ICH-GCP standards are maintained
* Collaborate closely with project management, regulatory affairs, and the wider study team
What We’re Looking For:
* Minimum 3–5 years of independent CRA experience in Germany
* Proven hands-on experience preparing and submitting Initial Applications and Substantial Modifications via CTIS (Part 1 & Part 2) under EU-CTR 536/2014
* Strong background in site start-up and monitoring (early phase oncology experience is a strong plus)
* Native or fully fluent German
* Currently based in Germany with ability and willingness to travel for site visits
* Previous CRO experience strongly preferred
* Proactive, reliable, and comfortable working autonomously
Study Scope:
* Early phase (Phase I/Ib–II) oncology studies
* Flexible 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