Job Description

Job Description

Job Description

About Ceribell

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, and is being used in hundreds of community hospitals, large academic facilities and major IDN's across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement!

Position Overview :

We are seeking a detail-oriented and proactive Clinical Research Associate (CRA) to join our Clinical Affairs team. The CRA will be responsible for monitoring clinical trials for medical devices to ensure compliance with clinical protocols, Good Clinical Practice (GCP), ISO 14155, and applicable regulatory requirements (e.g., FDA). The ideal candidate has experience in medical device trials and thrives in a fast-paced, innovation-driven environment.

What you'll do:

• Study Monitoring:
• 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.
• Regulatory Compliance:
• Ensure regulatory submissions and approvals are in place before trial initiation.
• Maintain knowledge of FDA and other global regulations relevant to medical device trials.
• Site Management:
• Serve as the primary point of contact for clinical sites.
• Provide training to site staff on study protocols and data collection systems.
• Manage and resolve site issues and queries promptly.
• Support preparation and maintenance of clinical trial documentation such as the Trial Master File (TMF), site binders, and site regulatory documentation.
• Documentation & Reporting:
• Maintain Trial Master File (TMF) documentation in compliance with SOPs.
• Draft monitoring reports, follow-up letters, and site visit summaries.
• Assist in the development of study protocols, CRFs, ICFs, and other clinical documents.
• Cross-functional Collaboration:
• Work closely with clinical project managers, regulatory affairs, quality assurance, and R&D.
• Support clinical strategy discussions and device lifecycle planning.

What We're Looking For:

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or related field.
• 3+ years of experience monitoring clinical trials, preferably in the medical device industry, with sponsor-side exposure.
• Experience working in Neuroscience space.
• Strong understanding of ISO 14155, FDA 21 CFR Part 812, and ICH-GCP guidelines.
• Experience with EDC systems (e.g., TrialMaster, REDCap, or similar).
• Strong attention to detail and ability to manage multiple priorities under pressure.
• Proficient in Microsoft Office and Teams; familiarity with Google Workspace and Dropbox is a plus
• Excellent written and verbal communication skills.
• Willingness to travel up to 30%

Preferred Qualifications:

• Master's degree or advanced clinical/scientific training.
• Experience with Class II or III medical devices.
• Certification (e.g., ACRP, SOCRA) is a plus.

Salary Range:

• SF Bay Area/NY Metro/LA Metro: $134,000 - $164,000 per year
• National: $107,000 - $128,500 per year

In addition to your base compensation, Ceribell offers the following:

• Annual Bonus + Equity Opportunity
• 100% Employer paid Health Benefits for Employees
• 50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection)
• 100% paid Life and Long-Term Disability Insurance
• 401(k) with a generous company match
• Employee Stock Purchase Plan (ESPP) with a discount
• Monthly cell phone stipend
• Flexible paid time off
• 11 Paid Holidays + 5 Company Wellness Days
• Excellent parental leave policy
• Fantastic culture with tremendous career advancement opportunities
• Joining a mission-minded organization!

Compensation Range

$107,000—$164,000 USD

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