Senior Clinical Research Associate

About the role

TFS HealthScience is building a network of freelance Senior Clinical Research Associates for an upcoming ophthalmology project. The role is home‑based in Denmark with extensive travel to study sites, supporting unmasked monitoring activities and ensuring protocol compliance.

Key responsibilities

• Monitor clinical trials on‑site and remotely, following TFS and sponsor SOPs, GCP and ICH guidelines.
• Verify informed consent, subject safety, data integrity and investigational product accountability.
• Prepare and submit Monitoring Visit Reports, track corrective actions and update CTMS and eTMF.
• Participate in audits, inspections and site supply management as needed.

Required profile

• Bachelor’s degree in life sciences or nursing (or equivalent).
• More than 5 years of independent on‑site monitoring experience, including at least 1 year as an unmasked monitor.
• Minimum 1 year experience in ophthalmology, preferably retina indications.
• Willingness to travel 60‑80% of the time, including overnight and abroad.

Required skills

• Good Clinical Practice (GCP) and ICH guideline knowledge.
• Proficiency with Clinical Trial Management Systems (CTMS) and electronic Trial Master Files (eTMF).
• Investigational product accountability and documentation management.
• Strong written and verbal communication in English.

What we offer

• Competitive freelance compensation package.
• Comprehensive benefits and opportunities for professional growth.
• Collaboration within a global CRO focused on patient safety and innovation.