Lead Clinical Research Associate

November 28, 2024

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Ora

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Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 45 years, we have proudly helped our clients earn more than 85 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world's most extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.

Allergy • Dry Eye • Retina • Anti-Infective • Anti-Inflammatory

201 - 500 employees

📋 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.