Clinical Research Associate

Meet Life Sciences; Berlin; Hybrid; EUR 96.432 - 151.536; Teilzeit

Zusammenfassung

A leading life sciences consulting firm is looking for a Freelance Clinical Research Associate in Germany. This remote role involves on-site monitoring visits and requires 3-5 years of experience in CRA functions, especially in early phase oncology studies. Ideal candidates should be fluent in German and comfortable working autonomously. The position offers flexible part-time work at up to €90/hour, starting ASAP.

Qualifikationen

• 3–5 years of independent CRA experience in Germany.
• Proven experience with CTIS applications under EU-CTR 536/2014.
• Strong background in early phase oncology monitoring.
• Reliable and comfortable working autonomously.

Aufgaben

• Oversee site start-up activities including feasibility and site activation.
• Perform routine monitoring and close-out visits.
• Ensure ongoing regulatory compliance.
• Act as the primary CRA contact for German sites.

Kenntnisse

German fluency

Independent CRA experience

CTIS expertise

Regulatory compliance

Site start-up experience

Jobbeschreibung

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.

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.

[e-mail]

Seniority level: Mid‑Senior level

Employment type: Contract

Job function: Research