Unblinded CRA in Germany

Fortrea; Deutschland; Vor Ort; EUR 55.000 - 70.000; Vollzeit

Benefits dieser Stelle

Sponsor environment

Structured onboarding

Flexible working model

Global career growth

Inclusive culture

Zusammenfassung

Fortrea is seeking an unblinded Clinical Research Associate to support sponsor-dedicated studies across Germany. The role involves unblinded monitoring in line with ICH-GCP, ensuring patient safety, data integrity, and regulatory compliance at study sites.

You will coordinate with site staff, maintain eTMF and regulatory files, and contribute to audit readiness in a collaborative global environment. German and English fluency are required, with travel across Germany as needed.

Qualifikationen

• Bachelor’s degree in Life Sciences or related field.
• Minimum 1 year monitoring experience in clinical research as a CRA.
• Knowledge of ICH-GCP guidelines and clinical trial processes.
• 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 fluency

English fluency

Organizational skills

Communication skills

Ausbildung

Bachelor’s degree in Life Sciences

Tools

eTMF system

Jobbeschreibung

Join a sponsor-dedicated model supporting cutting-edge clinical trials in Germany. As an unblinded Clinical Research Associate , 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 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.