The Clinical Research Associate II (CRA II) performs and coordinates all aspects of the clinical monitoring and site management 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 responsible for supporting study team management by providing input into monitoring tools and process development as well as training for newly assigned project CRAs.
Required to travel is up to 80%. Applicants must live within a 60 minute commute of a US metropolitan airport.
Responsibilities and duties include, but are not limited to: