Lead Clinical Research Associate
November 28
Description
• Ora’s Lead Clinical Research Associate (Lead CRA) develops strong clinical site relationships and is accountable for hands-on delivery of project tasks. • Work independently and partner with the CRA line Manager to ensure compliance. • Manage study activities through ongoing tracking and review of study progress. • Conduct review of CRA visit reports within required timeframe. • Handle escalations for site management questions and issues for assigned projects. • Develop and deliver presentations & training to clients, colleagues and professionals, as required. • Travel Requirements up to 25%.
Requirements
• Bachelor’s degree with 5 years’ experience as a Clinical Research Associate or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education. • Prior team and/or site lead experience. • Ophthalmic experience strongly preferred. • Understand how to properly assess an investigative site’s capabilities for conducting clinical research. • Ability to monitor and report on the progress of the trial from start-up to completion. Knowledge of how to select and qualify an investigative site. • Strong attention to detail in order to review CRA visit reports. • Extensive experience in the conduct of site evaluation, initiation, interim, and close-out visits. • Advanced Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs). • Multilingual communication is a plus.
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