The Clinical Research Associate (CRA) is responsible for effectively managing investigational sites in compliance with study protocols, IRB requirements, applicable FDA regulations, and company procedures. With a reasonable level of guidance and under the direction of the Manager, Clinical Research, this position assists in the study execution from start-up to close-out at assigned study sites, including training site personnel, monitoring, reporting, and completion of site visit reports.
This position will primarily cover the Western U.S., with occasional travel throughout the country. The candidate needs to be based in the Phoenix, AZ area. Only qualified applicants need apply. Rheumatology experience is preferred.
Essential Job 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, 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 degree (Health Science or RN preferred)
· Minimum 2 years of experience in medical device or pharmaceutical industry directly supporting investigational clinical studies
· Working knowledge of CFRs, IDE, PMA, GCPs and ICH Guidelines
· Demonstrate strong interpersonal and organizational skills
· Have excellent verbal and written communication skills along with a positive attitude
· Able to work in a fast-paced environment and complete tasks independently and efficiently with a high attention to detail and accuracy
- Advanced written and oral communication skills
- High attention to detail and accuracy
- MS Office Productivity Tools
- Proven ability to work independently and is self-directing, self-motivating and is accustomed to working in a small company environment
- Comfortable interacting with external personnel such as hospital and clinical site professionals.
- Strong, effective presentation and interpersonal skills
- 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 the Company
This is a western region 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. The candidate needs to be based in the Phoenix, AZ area.
SetPoint Medical is a clinical stage medical device company developing the first implantable neurostimulation device for the treatment of autoimmune diseases.