Position Overview

Supports department management in post-market clinical research efforts. Job duties:
  • 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 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.
  • Travel required (up to 25%).
  • Performs other duties and responsibilities as assigned.

    1. Bachelor’s Degree in a related field or equivalent experience (Life Science or Engineering preferred).
    2. Minimum of three (3) years of clinical research experience, preferably in the medical device industry.
    3. Strong knowledge of clinical research concepts, terminology, and regulations/guidelines such as FDA Title 21 and Good Clinical Practice (GCP).
    4. Outstanding detail-orientation and organizational/time management skills.
    5. Strong collaborative skills with demonstrated ability to work with site coordinators and other internal/external business partners.
    6. Proficiency in MS Office (Word, Excel, Access, PowerPoint) and Adobe Acrobat.
    Desired Qualifications
    1. Ability to understand the clinical therapies, procedures, and devices that form the basis of the organization’s research.
    2. Experience using Electronic Data Capture systems.
    3. Experience supporting post-market clinical studies.
    4. Global and/or IDE/PMA study experience.