Position Overview

The Sr. CRA supports project managers and/or Director, Post-Market Clinical Programs in post-market clinical research efforts.
  • Supports startup and execution of post-market clinical studies in line with institutional, GCP, regulatory, and compliance requirements
  • Assists project managers in protocol development as well as in the IRB/ethics approval process and audit preparation
  • Reviews and prepares technical documentation including informed consents, case report forms, study tools, and study training documents
  • Supports study project managers in budget and contract negotiations with clinical sites
  • Performs study site qualification visits, site initiation visits, and training of site staff, monitors, and vendors
  • Leads communication with study site/subsite personnel, monitors, vendors, and CROs/coordinating centers
  • Partners with study project managers to track study data, enrollment trends, and other metricsPerforms other duties and responsibilities as assigned
    • Bachelor’s Degree in a related field or equivalent experience (life science or engineering preferred)
    • Minimum of 5 years of clinical research experience preferably in the medical device industry
    • Experience supporting post-market clinical studies desired
    • Global and/or IDE/PMA study experience
    • Protocol development
    • ICF/CRF experience
    • Travel required (up to 25%)
    • In-house position based at Aliso Viejo, CA corporate headquarters
    • Strong knowledge of clinical research concepts, terminology, and regulations/guidelines such as FDA Title 21 and Good Clinical Practice (GCP)
    • Ability to understand the clinical therapies, procedures, and devices that form the basis of the organization’s research and to review and understand related reports and literature
    • Ability to identify data trends and prepare related reports
    • Outstanding detail-orientation and organizational/time management skills
    • Strong collaborative skills with demonstrated ability to work with physicians, site coordinators, and other internal/external business partners
    • Proficiency in MS Office (Word, Excel, Access, PowerPoint) and Adobe Acrobat
    • Experience using Electronic Data Capture systems desired