Position Overview

Position Overview
  • 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 assists in the preparation of 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.
  • Coordinates and participates in study site qualification visits, site initiation visits, and the training of site staff, monitors, and vendors.
  • Facilitates 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 metrics.
  • Performs other duties and responsibilities as assigned.
    • Minimum of 5 years of clinical research experience preferably in the medical device industry
    • 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.
    • Outstanding detail-orientation and organizational/time management skills.
    • Strong collaborative skills with demonstrated ability to work with site coordinators and other internal/external business partners.
    • Proficiency in MS Office (Word, Excel, Access, PowerPoint) and Adobe Acrobat.

    Desired Qualifications
    • Experience using Electronic Data Capture systems.
    • Bachelor’s Degree in a related field or equivalent experience (life science or engineering preferred).
    • Experience supporting post-market clinical studies.
    • Global and/or IDE/PMA study experience
    Additional Information
    • The primary work location for this position is Aliso Viejo.
    • Travel required (up to 25%).
    • Candidates must be eligible to work in the U.S. and not require visa sponsorship.
    • For more information, visit our web site at www.microvention.com