Ora
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
Clinical Research Associate II
February 15
Ora
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
• Develop strong clinical site relationships, ensuring performance and compliance with protocols. • Work with oversight of Lead CRAs and Line Manager. • Monitor site activities with ICH/GCP and local regulations. • Remote and on-site monitoring for data accuracy and subject safety. • Conduct various site visits ensuring clear and comprehensive documentation. • Manage and maintain information in CTMS and eTMF. • Identify and resolve site performance and compliance problems. • Adhere to Ora’s quality system and regulatory requirements.
🎯 Requirements
• Bachelor’s degree with 2 years’ experience as a Clinical Research Associate or equivalent combination of education, training, and experience. • Ophthalmic experience is strongly preferred. • Capacity to routinely assess protocol and GCP compliance. • Demonstrated ability to verify source data to reported data. • Strong attention to detail to review the completeness of the investigator site file. • Knowledge of the federal regulations governing research and Good Clinical Practices (GCPs). • Ability to read and comprehend a clinical research protocol. • Proficiency with Excel, CTMS, and EDC. • Multilingual communication is a plus.
🏖️ Benefits
• Medical and Dental coverage after 6 months of service for per diem workforce, • Gender and race diversity in hiring encouraged. • Inclusive and supportive work environment,
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