Clinical Research Associate

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)

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.

• 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

• 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

• 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 Linked In / email if you're interested.

Kos.hatsi

Seniority level:
Mid‑Senior level

Employment type:

Contract

Job function:
Research