Regulatory Assistant - Clinical Trials Office

Australia, Canada, France, Germany, India, United Kingdom, United StatesFull-TimeMiddle
Salary not disclosed
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Job Details

Required Skills
DocumentationData entry

Requirements

  • Bachelor's degree, preferably in biological sciences, health sciences, or life sciences
  • Equivalent combination of education and experience required
  • Experience in a clinical research capacity desired
  • Computer skills required
  • Knowledge of database software applications desired

Responsibilities

  • Assists with regulatory functions in support of clinical research activity.
  • Assists in preparation of protocol submissions to Institutional Review Boards (IRBs) and provides updates on submission status
  • Assists in preparation of other required regulatory documents
  • Distributes approved documents
  • Relays information to clinical research staff
  • Assists with data entry including collecting, entering and maintaining data and documents in the OnCore electronic database
  • Assists with monitoring visits
  • Assists with regulatory issues
  • Creates and maintains regulatory files
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