Clinical Research Associate - Western Region
Fully Remote Offsite
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.