Senior Clinical Research Associate

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 Freelance Senior Clinical Research Associate (SCRA) with strong ophthalmology experience, particularly in retinal disorders, in Melbourne Australia. 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

• Clinical Trial Oversight – Lead site monitoring activities for ophthalmology trials, ensuring adherence to protocol, GCP, and regulatory requirements.
• Risk-Based Monitoring – Implement risk-based approaches to ensure proactive issue resolution and maintain trial quality.
• Regulatory Compliance & Reporting – Manage ethics committee submissions, amendments, and periodic regulatory reporting, including safety event notifications.
• Site Activation & Support – Contribute to site activation, including Site Initiation Visits (SIVs) and investigator training.
• Data Quality & Documentation – 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 – A plus but not required.
• Regulatory Knowledge – Familiarity with local and international regulatory requirements.
• Communication & Collaboration – Strong interpersonal skills to engage effectively with sponsors and site staff.

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

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.