As a Freelance Clinical Research Associate (CRA), you will play a key role in supporting the execution of a clinical trial at a single site in Belgium. This is a part-time assignment (approximately 0.25 FTE) over an estimated duration of 18 months. You will ensure that the study is conducted in compliance with regulatory requirements, protocols, and quality standards, while acting as a key link between stakeholders.
Responsibilities:
- Conduct monitoring visits (approximately 8 visits over the project duration)
- Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements
- Act as the primary point of contact between the sponsor and the clinical site
- Review and verify clinical data and source documentation
- Support site initiation, monitoring, and close-out activities
- Identify and escalate potential risks or issues impacting study progress
- Maintain accurate and timely documentation and reporting
