Position Overview

Responsible for coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and MicroVention SOPs. Job duties:
  • Serve as a member on project teams completing tasks as assigned by the team.
  • Manage the conduct of clinical studies in accordance with approved protocols and good clinical practices.
  • Understand, read, and prepare technical documentation including, informed consents, study forms, and study training documents.
  • Responsible for collecting and reviewing site regulatory documents.
  • Maintain device accountability records.
  • Interface with monitors/CROs to address and resolve queries.
  • Work 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).
  • Perform additional responsibilities as assigned.

    1. Bachelor’s degree in related field (Life Science degree preferred).
    2. Minimum two (2) years of direct clinical research experience preferably in the medical device industry.
    3. Knowledge of FDA regulations for clinical trials and clinical procedures.
    4. Strong collaborative skills with demonstrated ability to work with physicians, site coordinators and others within the company.
    5. Experience using technologies for clinical research (electronic data capture and clinical trial management systems).
    6. Excellent written and verbal communication skills, including computer literacy.
    7. Proficient computer skills including MS Office (e.g., Word, Excel, Access, PowerPoint, Outlook, Teams, etc.).
    Desired Qualifications
    1. Clinical research expertise in various therapeutic areas (preferred areas: Neurovascular and/or Cardiovascular).
    2. Experience in the medical device industry preferred.