4h ago
Clinical Research Associate II
Remote, Australia
$75,000-$95,000 / year
J
full-timemid RemoteClinical Research Organization
🛠 Tech Stack
💼 About This Role
You'll serve as the primary point of contact for study sites in clinical trials, ensuring patient safety and data integrity. You'll independently conduct all types of site visits from pre-study to close-out, adhering to ICH-GCP and regulatory requirements. This role integrates deep scientific knowledge with advanced data sciences to support oncology and rare disease studies.
🎯 What You'll Do
- Conduct on-site and remote monitoring visits including pre-study, initiation, routine, and close-out.
- Review and maintain Investigator Site File (ISF) and Trial Master File (TMF) accuracy.
- Manage serious adverse event (SAE) reporting and protocol deviation tracking.
- Collaborate with sites to ensure subject recruitment and retention strategies.
📋 Requirements
- Bachelor's degree in a scientific or healthcare discipline.
- Minimum 2 years of on-site monitoring experience in clinical research.
- Proficiency in Microsoft Office suite (Outlook, Word, Excel).
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