Clinical Research Associate

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 IDNs 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 youll 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 Were Looking For:

• Bachelors 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:

• Masters 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: $134000 - $164000 per year
• National: $107000 - $128500 per year

A candidates final salary offer will be based on their skills education work location and experience and thus it may differ from the posted range. Compensation may also include bonuses consistent with Ceribells corporate compensation plan. Note the above description is not all-encompassing and Ceribell reserves the right to change or modify job duties and assignments at any time.

In addition to your base compensation Ceribell offers the following:

• Performance-based incentive compensation (varies by role)
• Equity opportunities
• 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!

Application Deadline: Ongoing

Equal Opportunity Employer
Ceribell is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex (including pregnancy childbirth and related medical conditions) sexual orientation gender identity or expression national origin age marital status disability veteran status or any other characteristic protected by law. Any applicant with a disability who requires an accommodation during the application process should contact to request reasonable accommodation.

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