Activities supported by regulatory affairs include, but may not be limited to: preparation and submission of initial protocol, amendment, and continuing review submissions to the Protocol Review Committee, IRB, and ancillary committees; tracking evidence of protocol and IRB-required training for all research staff; maintenance and sharing of regulatory files with study sponsor monitors, auditors and inspectors to ensure compliance with protocol requirements, university and applicable authorities; receipt and tracking of safety reports; collaborating with CTO staff, laboratory and pharmacy staff regarding study status changes; and serving as a liaison between the CTO, research staff and study sponsor when communicating regulatory matters. Works closely with investigators and other study team members including the project manager, for projects or programs of a small size or sections of medium projects and programs to consult, conduct analysis, and identify trial objectives and requirements within specific parameters.