Clinical Research Associate

The Clinical Research Associate may be regionally based and is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications. The CRA will support project teams in the placement, implementation, communication, site management, recruitment and retention (R and R;) issue identification and resolution, and activities required at the conclusion of clinical studies, as stipulated in the monitoring plans for assigned projects.
The CRA will expand his/her responsibilities as directed by the Clinical Project Leader (CPL) or DOCS Operations Manager to include fostering the development of the monitoring program and/or facilitating the objectives of the clinical project teams. The CRA may also be asked assist in completing special projects and assignments to further advance the monitoring program and its contributions to the clinical research department.