Senior Clinical Research Associate
- 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.
- Prior experience in clinical trial monitoring within a CRO, biotech, or pharmaceutical company.
- At least 1 year of 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.
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