Clinical Research Associate, Sr.

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 assists in the implementation of controlled clinical studies of MicroVention products.
  • Manages 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.
  • Conducts 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).
  • Supports budget and contract negotiations with clinical sites.
  • Assists in writing clinical study reports by reviewing tables and listings generated from study data
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
  • Performs additional responsibilities as assigned

Job Details

    1. Bachelor’s degree in related field (Life Science degree preferred).
    2. Minimum six (6) 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. General computer skills including Office (Word, Excel, Access, PowerPoint).
    8. Travel required (up to 25%).
    Desired Qualifications
    1. Clinical research expertise in various therapeutic areas (preferred areas: Neurovascular and/or Cardiovascular).
    2. Experience in the medical device industry preferred.