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

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