Senior Clinical Research Associate

TFS HealthScience; London; On-site; GBP 40,000 - 80,000

Job description

TFS HealthScience is a global, mid-sized Contract Research Organization (CRO) dedicated to supporting biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions to help bring innovative therapies to patients worldwide.

We are currently seeking a Senior Clinical Research Associate (SCRA) with strong ophthalmology experience, particularly in retinal disorders, based in the UK. This role involves working with a key sponsor on gene therapy and retinal disease studies, ensuring high-quality execution, regulatory compliance, and effective risk-based monitoring.

Key Responsibilities:

• Lead site monitoring activities for ophthalmology trials, ensuring adherence to protocol, GCP, and regulatory requirements.
• Implement risk-based approaches to ensure proactive issue resolution and maintain trial quality.
• Manage ethics committee submissions, amendments, and periodic regulatory reporting, including safety event notifications.
• Contribute to site activation, including Site Initiation Visits (SIVs) and investigator training.
• Ensure proper trial documentation, monitor data integrity, and support study closeout.

Qualifications:

• Prior experience in clinical trial monitoring within a CRO, biotech, or pharmaceutical company.
• Therapeutic expertise in ophthalmology trials.
• Experience in retinal disorders.
• Gene therapy experience is a plus but not required.
• Familiarity with local and international regulatory requirements.
• Strong interpersonal skills to engage effectively with sponsors and site staff.

Join us in driving forward cutting-edge clinical research in ophthalmology and beyond.