thevascularcaregroup

thevascularcaregroup

Clinical Research Coordinator

Wellesley, Massachusetts, United States

Sponsorship not specifiedDetected 22 hours ago
EHR/EMRClinical TrialsClinical ResearchFDA RegulatoryResearch

About the role

  • Trials managed include device and drug trials.
  • The trials range from being first in main pilot studies, IDE trials to post-market registry trials.
  • We utilize a robust clinical trial management system that enables us to store all subject binders and regulatory binders electronically greatly facilitating remote management of trials and regulatory compliance.

Responsibilities

  • Support activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state, and industry sponsor regulations
  • Assist in building electronic templates into CTMS for new trials to create eSource

Requirements

  • Willingness to drive between TVCG sites to fulfill research requirements required
  • Assist with gathering required regulatory documents for new trials and attend training sessions for new trials
  • Must be detailed oriented, facile with computer systems, able to work independently and willing to take on challenges

Nice to have

  • 3-5 years of experience in a clinical research capacity or knowledge in clinical research preferred
  • Clinical experience in a surgical specialty field required
  • vascular preferred

Benefits

  • Education/Experience
  • Bachelor's Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required
  • Knowledge of medical terminology required
  • Computer skills required (much of the work involves accessing Electronic Medical Records and Electronic Data Capture systems)

Visa & Work Authorization

  • compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state, and industry sponsor regulations
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