Ref #: 28918

Employment type: Permanent - Full-Time

Location: US-Florida

Posted: 07-May-2021

Description

• The Clinical Research Associate is 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&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 Research Manager [CRM] or Clinical Project Leader [CPL] to include fostering the development of the monitoring program and/or facilitating the objectives of the clinical project teams. The CRA will also assist the CRM/CPL, as directed, in the training, mentoring and supervision of CRAs, assisting in co-monitoring of sites and in completing special projects and assignments to further advance the monitoring program and its contributions to the clinical research department.