Lead Clinical Research Associate

March 15

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Ora

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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

• At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. • The Lead Clinical Research Associate (Lead CRA) develops strong clinical site relationships and is accountable for hands-on delivery of project tasks in addition to delegation and oversight of more junior CRA’s project tasks, providing advice and guidance to help achieve high performance and quality project deliverables. • Our Lead CRA’s will work independently and partner with the CRA line Manager to ensure Ora’s compliance with study conduct by monitoring the site activities regarding ICH/GCP and country regulations, Ora’s policies, and Standard Operating Procedures (SOPs) and sponsor requirements. • The Lead CRA will work in collaboration with Ora’s Quality Assurance and Regulatory teams in addition to the external sponsors and sites through all phases of the trial. • May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives. • Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors. • 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. • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work. • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth. • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.