Clinical Research Associate in Duisburg

Overview

In this CRA role, you will monitor and oversee clinical studies at investigative sites to ensure quality and compliance with protocol, SOPs, ICH-GCP, and regulations. You will be involved in study setup, regulatory submissions, and site activities, gaining protocol expertise across one to two studies. The role offers meaningful impact in a smaller CRO where your voice matters and you can influence outcomes. Expect reasonable travel and a strong focus on work-life balance, with support from direct line management.

Verantwortungsbereiche

• Monitor progress of clinical studies at investigative sites to ensure conduct, recording and reporting per protocol and ICH-GCP
• Coordinate study setup activities (identify investigators, regulatory submissions, pre-study and initiation visits)
• Ensure compliance with SOPs and applicable regulations across studies
• Support regulatory submissions and site readiness
• Maintain proactive communication with project teams and stakeholders
• Identify risks and propose mitigation strategies
• Uphold quality and outcomes of study activities
• Collaborate with cross-functional teams to drive study success

Zentrale Anforderungen

• Graduate or postgraduate degree in a scientific or healthcare discipline
• At least one year as a CRA in a CRO or pharma/biotech environment or equivalent experience
• Site management or equivalent clinical research experience
• Excellent communication and organizational skills; team player; client-focused
• Availability for domestic travel up to 50-60% (international travel for senior roles)
• Fluency in English and German
• Experience in oncology, CAR-T or FIH studies (phase III)

• calm and thoughtful
• responsive and prepared
• high attention to detail
• ICH-GCP knowledge and regulatory compliance
• SOPs and quality systems
• study start-up and monitoring activities