About the Role
We are looking for an experienced CRA I/II (depending on experience) to support a high-profile pre-approval cardiovascular medical device. This role involves frequent site monitoring, ensuring patient safety, regulatory compliance, and high-quality data collection.
Key Responsibilities
- Conduct site initiation, monitoring, and close-out visits.
- Oversee site compliance with study protocols, GCP, and regulations.
- Maintain Investigator Site Files and ensure accurate documentation.
- Support recruitment, retention, and site performance.
- Troubleshoot site issues and implement corrective actions.
- Collaborate with investigators, IRBs/ECs, vendors, and internal teams.
- Provide regular updates on site and trial progress.
What We’re Looking For
- Bachelor’s degree in Life Sciences (or equivalent).
- On-site monitoring experience (medical device preferred).
- Background in neurovascular or cardiovascular trials is a plus.
- Strong organizational and communication skills.
- Proficiency with Microsoft Office tools.
- Willingness to travel extensively across BE.
Solliciteren