Clinical Research Associate II – Home Based – Pleno
• The Clinical Research Associate II 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.
• Minimum 2 years industry experience as a CRA, or equivalent; experience in clinical medicine (e.g. nursing, laboratory, radiology, pharmacy) or pre-clinical area (e.g. pharmacology, toxicology) desired.
• Health related background and BS Degree required.
Mon, 22 Feb 2021 14:02:15 +0000