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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