Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography (“EEG”) platform specifically designed to address the unmet needs of patients in the acute care setting.
Requirements
- Strong understanding of ISO 14155, FDA 21 CFR Part 812, and ICH-GCP guidelines.
- Experience with EDC systems (e.g., TrialMaster, REDCap, or similar).
- Proficient in Microsoft Office and Teams; familiarity with Google Workspace and Dropbox is a plus
- Experience with Class II or III medical devices.
- Certification (e.g., ACRP, SOCRA) is a plus.
Responsibilities
- Perform site qualification, initiation, monitoring, and close-out visits.
- Ensure adherence to protocol, GCP, ISO 14155, and applicable regulations.
- Verify that study data is accurate, complete, and verifiable from source documents.
- Track enrollment and site performance metrics.
- Ensure regulatory submissions and approvals are in place before trial initiation.
- Provide training to site staff on study protocols and data collection systems.
- Maintain Trial Master File (TMF) documentation in compliance with SOPs.
Other
- 3+ years of experience monitoring clinical trials, preferably in the medical device industry, with sponsor-side exposure.
- Experience working in Neuroscience space.
- Strong attention to detail and ability to manage multiple priorities under pressure.
- Excellent written and verbal communication skills.
- Willingness to travel up to 30%
