Clinical Research Associate II
1 settimana fa
At Ora, we're building a future of ophthalmic clinical research as the world's leading full-service firm. We guide clients across all phases to efficiently bring new products and therapies to market.
We have over 45 years of experience in clinical research with more than 85 new product approvals. Our teams use refined methodologies, integrated data solutions, and global regulatory strategies to deliver innovative results.
The Clinical Trial Associate II assists Project Managers in study conduct for posterior, anterior, and med device projects. They support feasibility by working with sites, generating contracts, collecting regulatory documents, and scheduling follow-up patient visits.
This role participates in start-up, study maintenance, and close-out activities under the guidance of Senior CTAs/Lead, Assistant Project Managers, and Project Managers. The CTA II liaises between field and office teams, working more autonomously and independently than the CTA I.
The key responsibilities include ensuring documentation, communication, and data collection align with study protocols and applicable SOPs, regulations, and guidelines. You'll lead the development of assigned study-related documents, participate in site management from start-up through closeout, collect and review site regulatory documents, and prepare essential documents packages.
You may assemble and distribute regulatory binders, provide monitors with Investigator Site File trackers, support project management activities, and maintain clinical study tracking systems.
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