Unblinded CRA in Germany

FTGER Fortrea Germany GmbH; München; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

FTGER Fortrea Germany GmbH is seeking a Clinical Research Associate (CRA) to perform unblinded monitoring activities in line with ICH-GCP guidelines at assigned sites across Germany.

You will ensure protocol compliance, data integrity, patient safety, and maintain study documentation (eTMF & regulatory files). Travel to Ruhrgebiet/Frankfurt and throughout Germany is expected, with a focus on site management in pharmacy settings.

Qualifikationen

• 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 the Ruhrgebiet or Frankfurt region and across Germany as required.
• Strong organizational skills with attention to detail.

Aufgaben

• 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.

Kenntnisse

German language

English language

Organizational skills

Ausbildung

Bachelor’s degree in Life Sciences

Jobbeschreibung

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 the Ruhrgebiet or Frankfurt region and across Germany 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

Learn more about our EEO & Accommodations request here.

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.