Unblinded CRA in Germany

Fortrea; München; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Benefits dieser Stelle

Structured onboarding

Development programs

Flexible work model

Global career growth

Zusammenfassung

Fortrea is seeking an unblinded Clinical Research Associate to support high-quality clinical trial delivery in Germany. You will perform unblinded monitoring activities, ensure protocol and data integrity, and maintain regulatory documentation across assigned sites.

The role involves travel within the Ruhrgebiet or Frankfurt region and across Germany, collaborating in a sponsor-dedicated, globally oriented environment with opportunities for development and on-boarding programs.

Qualifikationen

• Bachelor's degree or equivalent in life sciences.
• At least 1 year of CRA monitoring experience.
• Solid understanding of ICH-GCP guidelines and trial processes.
• Fluency in German and English (written and spoken).

Aufgaben

• Perform unblinded monitoring activities in line with ICH-GCP guidelines.
• Ensure protocol compliance, data integrity, and patient safety at sites.
• Maintain accurate study documentation including eTMF and regulatory files.
• Build relationships with site staff; act as primary contact for site management (pharmacy only).
• Contribute to audit readiness and inspection preparedness at site level.

Kenntnisse

Bachelor's degree

CRA experience

ICH-GCP knowledge

Unblinded studies

German & English

Travel willingness

Attention to detail

Ausbildung

Bachelor's degree in Life Sciences or related field

Jobbeschreibung

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