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
March 6
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
• To support our future growth in Europe we are seeking experienced Clinical Research Associates with ophthalmology experience. • We want welcome candidates who are passionate about advancing their careers in Clinical Research! • Ora’s Clinical Research Associate II (CRA II) develops strong clinical site relationships and is accountable for performance and compliance with assigned protocols at our sites. • You will ensure Ora’s compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora’s policies, and Sponsor SOPs by partnering cross-functionally within Ora. • Clear and sustained demonstration of the Ora Clinical’s Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
• Bachelor’s degree with 2 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. • 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 to reconcile and return/destroy test articles while conducting initiation, interim, and close-out visits. • Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs). • Ability to read and demonstrate comprehension of a clinical research protocol as well as understand the importance of following the protocol. • Proficiency with Excel, CTMS, and EDC. • Multilingual communication is a plus.
• Full-time employees of Ora working a minimum of 30 hours per week. • Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.
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