Clinical Research Associate II

2 days ago

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Ora

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

201 - 500

Description

• Clinical Research Associate II develops strong clinical site relationships and ensures compliance. • Monitor site activities in line with ICH/GCP and country regulations. • Responsibilities may differ based on specific business needs. • Travel Requirements up to 75%.

Requirements

• 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.

Benefits

• 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.