Clinical Research Associate

Position Overview 

The Clinical Research Associate (CRA) is responsible for clinical trial operations and site management. This position serves as the Sponsor (Ceribell Inc.) representative for clinical operations activities such as site start-up including site training, enrollment, data collection and management, monitoring, and site close-out. The CRA will liaise with central Institutional Review Board (IRB) to obtain approval on new projects and continuing review of existing projects. The CRA will ensure timely data collection and management of clinical data. The CRA will also assist in review and development of clinical trial documents such as the protocol, informed consent, and case report form. Project assignments will include both Ceribell-sponsored research and Investigator Initiated Studies (IIS). 

This role is located in Sunnyvale, CA or Los Angeles, CA. Also considering remote candidates in the Western US.

What You'll Do:

• Serves as the primary contact for clinical trial site personnel on one or more study protocols
• Responsible for site management activities including answering site questions on the study protocol, site training, device accountability and inventory management, site payments, adverse event management, and query management
• Ensures compliance with protocol and all regulatory policies, procedures and or guidelines during clinical studies by training / guidance of investigators and study personnel (CRC and or RA), and follow-up of corrective actions.
• Reviews and approves site specific informed consent documents 
• Reviews and negotiates site budgets
• Reviews and collects financial disclosure forms, investigator agreements, and physician licensing information
• Manages clinical operation activities such a creation of study newsletter and investigator and research coordinator meetings
• Ensures IRB approval at site and study level remains active during the clinical trial conduct 
• Conducts clinical trial site initiation, monitoring, and close-out visits  
• Ensures timely collection and management of clinical data 
• Reviews and reports data entry and data collection status at the study, site, and subject (patient) level 
• Administrative duties including upkeep of clinical trial document records in a central database 
• Works with sites to ensure all of the documentation for sites is collected prior to activating the site and maintained accordingly
• Understands and adheres to the Good Clinical Practice (GCP), FDA regulations, and Standard Operating Procedures (SOPs)
• May supervise other team members

What You'll Need:

• Bachelor’s degree required, or Associate degree plus 5 years’ experience as a CRA
• Certification in Good Clinical Practice (GCP) required
• 5+ years’ experience in clinical research 
• 2+ years management experience preferred
• Industry (sponsor) clinical research experience strongly preferred
• Must comply with competent authority regulations and company policy and procedures
• Understanding of FDA medical device regulations for clinical trials required
• Able to communicate with clarity, confidence, and empathy in verbal and written communication
• Experience with medical device clinical research is a plus
• Very organized and comfortable carrying out clinical study tasks remotely and on-site (travel w/in US)
• Excels under pressure, maintaining a calm demeanor
• Works well independently and with a team
• Strong interpersonal skills
• Ability to thrive in a dynamic creative start-up environment
• Able to focus on key project activities that are aligned with department and company goals
• Demonstrated proficiency with software tools including Google suite apps, Dropbox, Word, Excel, PowerPoint
• ACRP or SOCRA certification is a plus
• This position requires 40-60% travel

What We Offer:

• $125-135K + Bonus+  Ceribell Equity 
• 100% Employer paid Health Benefits for the Employee 
• Life & Long-term disability insurance paid 100% by Ceribell
• Flexible paid time off
• 11 Paid Holidays
• Maternity and Paternity Leave 
• Fantastic culture with tremendous career advancement opportunities