Freelance Clinical Research Associate

Freelance Clinical Research Associate

TFS HealthScience

Hamburg, Germany

About this role

As a Clinical Research Associate, you will support the initiation, on-site and remote monitoring, and close-out of clinical trial sites, ensuring participant safety, data integrity, and compliance with ICH-GCP, SOPs, and regulatory requirements.

Key Responsibilities

• Monitor clinical trials on-site and remotely in line with TFS/sponsor SOPs, ICH-GCP, and regulations;
• Ensure subject safety, protocol adherence, informed consent compliance, and data accuracy;
• Review source documentation and CRFs and verify Investigational Product management;
• Document monitoring activities in timely, accurate reports and escalate issues when needed;
• Maintain ISF and deliver required documents to TMF/eTMF; update CTMS and project systems;
• Support audits, inspections, and clinical supply management (as applicable).

Qualifications

• Bachelor’s degree in life sciences, nursing, or equivalent; 1+ year of relevant clinical experience;
• Solid understanding of medical terminology, GCP, ICH guidelines, and regulatory requirements;
• Strong communication, organization, and time-management skills; tech-savvy and detail-oriented;
• Ability to work independently and collaboratively in a matrix team environment;
• Fluent in English; flexible, proactive, analytical, and collaborative mindset.