Senior Clinical Research Associate

AL Solutions; Dortmund; Remote; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A global CRO is seeking a Senior Clinical Research Associate for a home-based position in Germany. The ideal candidate will be fluent in French and have over 3 years of independent monitoring experience. This role involves overseeing clinical trials across Germany and France, maintaining compliance, and contributing to impactful rare disease studies. It offers a competitive salary and clear career progression in an innovative environment.

Leistungen

Highly competitive salary

Flexibility of home-based working

Ongoing professional development

Qualifikationen

• At least 3 years of independent monitoring experience within a CRO or pharmaceutical environment.
• Strong knowledge of ICH-GCP and European clinical trial regulations.

Aufgaben

• Independently conduct qualification, initiation, monitoring, and close-out visits.
• Ensure full compliance with ICH-GCP, national regulations, and sponsor SOPs.
• Perform source data verification, investigational product accountability, and maintain accurate site files.
• Build and maintain productive relationships with site staff, offering continuous guidance and support.
• Identify and proactively resolve operational or site-level challenges.
• Maintain complete and accurate trial documentation across CTMS, eTMF, and EDC platforms.

Kenntnisse

Fluency in French

Professional proficiency in English

Independent monitoring experience

Knowledge of ICH-GCP

Ability to travel

Ausbildung

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field

Jobbeschreibung

Senior Clinical Research Associate – Germany (Home-Based, French Speaking)

Chloe O’Shea is pleased to be working with a small global CRO recognised for driving innovation and excellence in clinical development. We are seeking an experienced Clinical Research Associate to join a sponsor-dedicated team, home-based in Germany. This is a unique opportunity to contribute to rare disease studies while supporting both German and French sites, making fluency in French essential.

The Role

As a Senior CRA, you will play a pivotal role in the oversight and delivery of clinical trials across Germany and France. You will manage site activities independently, act as the primary contact for investigative sites, and ensure strict compliance with study protocols, ICH-GCP, and regulatory requirements in both countries. This position is ideal for CRAs eager to strengthen their expertise across diverse therapeutic areas within a supportive, sponsor-focused setting.

Key Responsibilities

• Independently conduct qualification, initiation, monitoring, and close-out visits.
• Ensure full compliance with ICH-GCP, national regulations, and sponsor SOPs.
• Perform source data verification, investigational product accountability, and maintain accurate site files.
• Build and maintain productive relationships with site staff, offering continuous guidance and support.
• Identify and proactively resolve operational or site-level challenges.
• Maintain complete and accurate trial documentation across CTMS, eTMF, and EDC platforms.

Requirements

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
• At least 3 years of independent monitoring experience within a CRO or pharmaceutical environment.
• Strong knowledge of ICH-GCP and European clinical trial regulations.
• Fluency in French is essential; professional proficiency in English required, German also needed.
• Flexibility to travel across Germany and France for site visits.
• Based in Germany, with the ability to work fully home-based.

What’s in It for You?

This role offers a highly competitive salary, with the flexibility of home-based working in Germany. You will gain invaluable international monitoring experience, working across both German and French sites on impactful rare disease trials. The organisation offers clear career progression pathways, ongoing professional development, and a culture that prioritises collaboration, balance, and wellbeing.

If you are an experienced CRA seeking to expand your expertise across borders and contribute to meaningful clinical research, we’d love to hear from you. Apply today to join a global team committed to advancing clinical development and improving patient outcomes.