Unblinded CRA based in Germany (Ruhrgebiet)

FTGER Fortrea Germany GmbH; München; Hybrid; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Flexible working model

Global career growth opportunities

Inclusive culture

Job summary

Fortrea Germany GmbH is seeking an unblinded Clinical Research Associate (CRA I or CRA II) to contribute to high-quality clinical research delivery within a sponsor-dedicated model in the DACH region.

The successful candidate will perform unblinded monitoring in line with ICH-GCP, ensure protocol adherence, data integrity and patient safety, and maintain regulatory documentation across sites, with travel within Germany and Austria as required.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• At least 1 year monitoring experience as a CRA.
• Understanding of ICH-GCP guidelines and trial processes.
• Strong interest in unblinded study conduct and Investigational Product management.
• Fluency in German and English (written and spoken).
• Willingness to travel within Germany and Austria as required.
• Strong organizational skills with attention to detail.

Responsibilities

• Perform unblinded monitoring activities in line with ICH-GCP guidelines and applicable regulations, including Investigational Product oversight.
• Ensure protocol compliance, data integrity, and patient safety at assigned sites.
• Maintain accurate and complete study documentation, including eTMF and regulatory files.
• Build strong relationships with site staff, acting as the primary point of contact for site management (pharmacy only).
• Contribute to audit readiness and ensure inspection preparedness at site level.

Skills

Fluent German & English

Education

Bachelor's degree in Life Sciences or related field

Job description

Join a sponsor-dedicated model supporting cutting-edge clinical trials in DACH. As an unblinded Clinical Research Associate (CRA I or CRA II level), you will contribute to high-quality clinical research delivery while gaining strong exposure to unblinded study activities in a collaborative global environment.

Key Responsibilities

• You will perform unblinded monitoring activities in line with ICH-GCP guidelines and applicable regulations, including Investigational Product oversight
• You will ensure protocol compliance, data integrity, and patient safety at assigned sites
• You will maintain accurate and complete study documentation, including eTMF and regulatory files
• You will build strong relationships with site staff, acting as the primary point of contact for site management (pharmacy only)
• You could contribute to audit readiness and ensure inspection preparedness at site level

Required Qualifications

• Bachelor’s degree in Life Sciences or related field (or equivalent experience)
• Initial experience in clinical research as a CRA with at least 1 year of monitoring experience
• Understanding of ICH-GCP guidelines and clinical trial processes
• Strong interest and knowledge in unblinded study conduct and Investigational Product management
• Fluency in German and English (written and spoken)
• Willingness to travel within Germany and Austria as required
• Strong organizational skills with attention to detail

What We Offer

• Opportunity to work in a sponsor-dedicated environment on innovative studies
• Structured onboarding and continuous development programs
• Flexible working model supporting work-life balance
• Access to global career growth opportunities within clinical operations
• Inclusive and collaborative culture with employee resource groups and wellbeing initiatives

At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.