Senior Clinical Research Associate
Senior Clinical Research Associate
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Job Description
TFS HealthScience is a global midsized Contract Research Organization (CRO) dedicated to supporting biotechnology and pharmaceutical companies throughout their clinical development journey. We provide fullservice 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 highquality execution regulatory compliance and effective riskbased monitoring.
Key Responsibilities
- Clinical Trial Oversight Lead site monitoring activities for ophthalmology trials ensuring adherence to protocol GCP and regulatory requirements.
- RiskBased Monitoring Implement riskbased 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 cuttingedge 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 fullservice global Contract Research Organization (CRO) we build solutiondriven 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 decisionmaking 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.
Employment Type
Full Time
