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