The Clinical Research Associate II (CRA II) performs and coordinates all aspects of the clinical monitoring process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho Standard Operating Procedures.
This position requires proven monitoring skills. The CRA II conducts site visits to assess site adherence to protocol and regulatory requirements as well as manages required documentation. The CRA II will also be responsible for ensuring the data remains audit ready and able to pass an audit by Rho, the Sponsor or a regulatory agency.
The CRA II will be part of a multi-disciplinary team that provides scientific, statistical, and operations and management support for federal clinical trials. In these trials, on-site monitoring is used in conjunction with extensive remote monitoring and site management. Thus, this role will work closely with the project manager, who has primary responsibility for site management, and the data manager.
Required to travel is up to 80%. The ideal candidate will be located in the Raleigh/Durham/Chapel Hill, NC area, however will consider non-local candidates who are willing to travel to and work in-office as needed.