Lead Clinical Research Associate

2 days ago

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Ora

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

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Description

• At Ora, we are building the future of ophthalmic clinical research. • The 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 Ora’s compliance with study conduct by monitoring site activities. • Conduct review of CRA visit reports within required timeframe, track CRA compliance and proactively escalate quality issues.

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.

Benefits

• Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1. • Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays. • Competitive salaries along with a 401K plan through Fidelity with company match. • Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. • Offering peace of mind to help you and your family feel secure. • We'll reimburse you to support your remote workspace and wellness purchases. • No matter what issues you're facing, New Directions is here to help you and your family. • Continued opportunities to grow and develop your career journey. • Opportunities to work with colleagues across the globe. • A chance to research new ophthalmic therapies that will impact patients across the globe.