MicroVentionTerumo

Clinical Research Assoc, Sr.

Position Overview

Responsible for coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs.
  • As a contributing member on project teams, assist in the implementation of controlled clinical studies of MicroVention products
  • 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
  • Manage device accountability process
  • Conduct site initiation visits and closure visits at clinical study sites
  • 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)
  • Support budget and contract negotiations with clinical sites
  • Assist 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
  • Perform additional duties as assigned

Job Details

Job ID 11704BR

Aliso Viejo, California, USA

Salary Range:

$80,000-$120,000 (Compensation could be higher based on education, experience and skill sets)

    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 (e.g., Word, Excel, Access, PowerPoint)
    Desired Qualifications
    1. Clinical research expertise in various therapeutic areas (preferred areas: Neurovascular and/or Cardiovascular)
    2. Experience in the medical device industry preferred