Clinical Research Associate II / Senior Clinical Research Associate - Rare Diseases and Cell & Gene Therapy

Position Overview

This full-time permanent Clinical Research Associate role based in Germany offers an opportunity to work on pioneering Cell & Gene Therapy clinical trials spanning from first-in-human to late-phase studies, aimed at addressing rare and orphan diseases. The position requires approximately 60–70% travel across Germany and selected European sites.

Key Responsibilities

• Conduct site qualification, initiation, routine monitoring, and close-out visits, ensuring adherence to ICH-GCP, protocols, and local regulations.
• Develop strong partnerships with Principal Investigators and site staff to facilitate study success.
• Monitor patient safety, compliance with protocols, and data quality throughout the trial lifecycle.
• Review source documents and verify clinical data in electronic data capture (EDC) systems.
• Provide protocol training and procedural support to site personnel.
• Identify and address site-related challenges proactively; escalate risks as necessary.
• Collaborate closely with Clinical Trial Managers and multidiscipline study teams.
• Manage timely collection of essential documents and maintain Trial Master File accuracy.
• Prepare for inspections and assist during sponsor and regulatory audits.

Candidate Profile

• Possess a Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
• Have prior independent CRA monitoring experience within CROs or pharmaceutical firms.
• Thorough understanding of ICH-GCP guidelines and European clinical trial regulations.
• Experience monitoring clinical studies from Phase I through Phase IV.
• Strong communication and stakeholder relationship management capabilities.
• Fluent in both German and English languages.
• Availability for extensive travel throughout Germany.

Preferred Qualifications

• Background in rare and orphan disease studies.
• Experience with Cell & Gene Therapy clinical trials.
• Knowledge of oncology, hematology, or Advanced Therapy Medicinal Products (ATMPs).
• Exposure to early-phase clinical trials and complex biologics or precision medicine programs.

Compensation and Benefits

• Competitive base salary plus annual performance-related bonus.
• Company car or allowance.
• Comprehensive benefits offering.
• Flexible home-based work arrangement.
• Opportunities for ongoing professional growth and career advancement.
• Engagement with highly innovative Cell & Gene Therapy programs impacting patient lives.
• Collaborative work with internationally recognized sponsors delivering transformative treatments.