The Clinical Research Associate II (CRA II) is responsible for effectively managing investigational sites in compliance with study protocols, IRB requirements, applicable FDA regulations, and company procedures. This position oversees study execution from start-up to close-out at assigned study sites, including training, monitoring, and reporting. The CRA II reports to the Manager of Clinical Research.

This position will primarily cover the Western US, with occasional travel throughout the country. The candidate needs to be based in the Phoenix, AZ area.

Essential Functions

Include but are not limited to the following:

• Conduct site qualification, initiation, monitoring and close-out visits, and submit timely reports
• Serves as the main contact for assigned study sites
• Ensure adherence to study protocols, company’s SOPs, and compliance with GCP guidelines and FDA regulations and IRB requirements
• Provide clinical support in the areas of implant procedure, basic troubleshooting, programming, and complaint reporting for the SetPoint System
• Review source documentation, case report forms, and data reports for accuracy, completeness, and timely submission
• Manage investigational product accountability
• Communicate and work with site investigators and research staff to ensure proper reporting of adverse events and protocol deviations and escalate critical compliance issues to manager promptly
• Respond to any protocol-related issues and timely escalate to management
• Collect and transfer required site documents for trial master file
• Provide site updates at study team meetings
• Participate in development of clinical study materials, such as source documentation, work instructions, patient recruitment materials and product training
• Attend relevant scientific meetings as directed

Education, Experience and Skills Requirements

• Bachelor’s Degree in science/health-related field (Health Science or RN preferred)
• 3 - 4 years of experience in medical device or pharmaceutical industry directly supporting investigational clinical studies
• Working knowledge of CFRs, IDE, PMA, GCPs and ICH Guidelines
• MS Office Productivity Tools
• Must have onsite monitoring experience
• Rheumatology study experience a plus

Success Competencies

• Able to work in a fast-paced environment and complete tasks independently and efficiently with minimal supervision
• Comfortable interacting with external personnel such as hospital and clinical site professionals
• Advanced written and oral communications skills with high attention to detail and accuracy
• Strong and effective presentation and interpersonal skills with a positive attitude
• Superior organizational skills, proven record of consistently following through on commitments
• Exceptionally team focused, self-motivating and passionate for innovation and quality
• Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside of SetPoint Medical

Location

This is a field position, and may require travel 50-70% of the time, with periods of more frequent travel. This position also requires occasional visits to company headquarters in Valencia, CA.

Company Description

SetPoint Medical is a clinical stage medical device company developing the first implantable neurostimulation device for the treatment of autoimmune diseases.