Position Overview

Position Overview
This position is responsible for coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and MicroVention SOPs.
  • Contributing member on project teams, and assisting in the implementation of controlled clinical studies of MicroVention products
  • Managing the conduct of clinical studies in accordance with approved protocols and good clinical practices
  • Understands, reads and prepares technical documentation including, informed consents, study forms, and study training documents
  • Responsible for collecting and reviewing site regulatory documents.
  • Manages device accountability process
  • Conduct Site Initiation Visits and Closure Visits at clinical study sites
  • Interfaces with monitors/CROs to address and resolve queries
  • Works closely with Project Manager(s) to ensure clinical studies are conducted in accordance with the protocol, GCP, MicroVention SOPs and all applicable regulations (e.g. FDA)
  • Support budget and contract negotiations with clinical sites
  • Assist in writing clinical study reports by reviewing tables and listings generated from study data.
  • Additional duties as assigned
    • Bachelor’s degree in related field (Life Science degree preferred)
    • 6 years direct clinical research experience preferably in the medical device industry.
    • Knowledge of FDA regulations for clinical trials and clinical procedures
    • Strong collaborative skills with demonstrated ability to work with physicians, site coordinators and others within the company
    • Excellent written and oral communication skills, including computer literacy
    • General computer skills including Office (Word, Excel, Access, PowerPoint)Experience using technologies for clinical research (electronic data capture and clinical trial management systems)
    Desired Qualifications
    • Clinical research expertise in various therapeutic areas (Preferred Areas: Neurovascular and/or Cardiovascular)