Senior Clinical Research Associate - Freelance

TFS HealthScience

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About The Position

TFS HealthScience is hiring a freelance Senior Clinical Research Associate at 0.4 FTE in the Czech Republic, as part of its CDS Ophthalmology team. The role involves taking ownership of investigator sites throughout the clinical trial lifecycle and ensuring studies comply with protocols, ICH-GCP guidelines, SOPs, and applicable regulatory requirements. The position works with project teams, investigators, vendors, and other stakeholders to support study delivery and quality.

Requirements

• Bachelor's degree in Life Sciences or a related field.
• 3–5 years of independent clinical monitoring experience as a CRA or Senior CRA.
• At least 1 year of experience in ophthalmology clinical trials, including Retinopathy, Age-Related Macular Degeneration (AMD), and/or Diabetic Macular Edema (DME) studies.
• Strong knowledge of ICH-GCP, clinical trial regulations, and monitoring best practices.
• Demonstrated experience independently conducting all monitoring visit types.
• Excellent site management, communication, and problem-solving skills.
• Ability to travel within the Czech Republic as required.

Responsibilities

• Independently manage assigned investigator sites throughout the entire study lifecycle.
• Conduct feasibility, pre-study, site initiation, routine monitoring, co-monitoring, quality oversight, and close-out visits.
• Ensure study milestones and site deliverables are achieved according to timelines.
• Verify source data and ensure accurate completion of Case Report Forms (CRFs).
• Review informed consent documentation, regulatory files, essential documents, and investigational product accountability records.
• Identify, document, and resolve protocol deviations and data discrepancies.
• Prepare monitoring reports, follow-up communications, and site correspondence.
• Ensure site personnel are appropriately trained and qualified to conduct study activities.
• Monitor site performance metrics and proactively address compliance or quality issues.
• Escalate risks and issues appropriately and drive timely resolution.
• Support audit and regulatory inspection readiness activities.
• Collaborate with project teams, investigators, vendors, and cross-functional stakeholders.
• Participate in study meetings, training sessions, and project-related activities.

Benefits

• Competitive compensation package.
• Comprehensive benefits.
• Opportunity for personal and professional growth in a rewarding environment.
• Collaborative and innovative team environment focused on making a difference in patients’ lives.

What This Job Offers

• Career Level: Senior