At ORA, we believe that health & wellbeing should be more accessible, convenient & personal. Backed by Antler.
About the role
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. Our CRA II’s will work with the oversight of the Lead CRA’s and Line Manager. As a CRA II, 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.
What they're looking for
- Responsibilities may differ slightly from the above based on specific needs of the business
- Develop strong site relationships and ensures continuity of site relationships through all phases of the trial
- Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
- Gain in-depth understanding of the study protocol and related procedures
- Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness
- Participate & provide input on site selection and validation activities
More about this role
POSITION TITLE: Clinical Research Associate II
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
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. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. 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. Today, our team continues to expand across the globe, with over 400 employees across North America, Europe, Asia, and Latin America.
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. Our CRA II’s will work with the oversight of the Lead CRA’s and Line Manager. As a CRA II, you will ensure Ora’s compliance of study conduct by monitoring the site...
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