Lead Clinical Research Associate

November 8

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Ora

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

201 - 500

Description

• Ora’s Lead Clinical Research Associate develops strong clinical site relationships and is accountable for project tasks. • Ensure compliance with study conduct by monitoring the site activities regarding ICH/GCP and country regulations. • Collaborate with functional groups within the company to support achievement milestones. • Conduct review of CRA visit reports within required timeframe and track CRA compliance. • 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.

Benefits

• Competitive salaries along with a structured pension plan. • Offering private medical insurance healthcare beginning day 1 provided by Vitality and SimplyHealth. • Offering peace of mind through Canada Life to help you and your family feel secure. • 25 days of annual leave + Birthday PTO + bank holidays. • We'll reimburse you to support your remote workspace and wellness purchases. • 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.