At ORA, we believe that health & wellbeing should be more accessible, convenient & personal. Backed by Antler.
About the role
Ora’s Clinical Trial Associate II (CTA II) assists Project Managers and study teams in clinical study conduct for clinical ophthalmic projects. They support the oversight feasibility including but not limited to, working with sites to generate contracts and budgets, collecting regulatory documents, and may be involved in scheduling follow up patient visits of all clinical sites and ensures compliance with (GCP) protocol along with overall clinical objectives.
What they're looking for
- Ensure study documentation, communication, training and data collection is aligned with study protocol adherence, and all applicable SOPs, regulations and guidelines
- Lead the development of assigned study-related documents (e.g., informed consent, source documents, study logs, etc.)
- Participate in all phases of clinical trial site management from study start-up, through study conduct and completing closeout activities
- Collect and review site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc.)
- Prepare essential documents package to support investigational product release for study and site approval as well as applicable study and site continuity report submissions and close-out submissions
- Create regulatory packages for IRB/IEC study and site submission, as well as applicable continuity report, and close-out submissions
More about this role
POSITION TITLE: Clinical Trial 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 Trial Associate II (CTA II) assists Project Managers and study teams in clinical study conduct for clinical ophthalmic projects. They support the oversight feasibility including but not limited to, working with sites to generate contracts and budgets, collecting regulatory documents, and may be involved in scheduling follow up...
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