• 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