Clinical Research Associate – Western Region

United States (Remote)        ·       Full time

Job Type: Full-time

Description

Position Description:

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. 

Requirements

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

Other Requirements:

• Advanced written and oral communication skills
• High attention to detail and accuracy
• MS Office Productivity Tools

Success Competencies:

• 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

Location:

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.

Company Description:

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

Please click here to apply.