Ubicación: Madrid, Madrid provincia
Descripción completa del empleo: POSITION TITLE: Clinical Trial Associate II
DEPARTMENT: Ora Europe
LOCATION: Remote, Spain
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.
The Role: Ora's Clinical Trial Associate II (CTA II) assists Project Managers in clinical study conduct for clinical ophthalmic projects in posterior, anterior, and med device.
They support the oversight feasibility including but not limited to, working with sites to generate contracts and budgets, collecting regulatory documents, and scheduling follow up patient visits of all clinical sites and ensures compliance with (GCP) protocol along with overall clinical objectives.
Ora's CTA II's participate in all phases of clinical studies including start up, study maintenance, and close-out activities in addition to performing additional day to day activities under the guidance of the Sr. CTA/Lead, Assistant Project Managers and Project Managers and liaise between field and office and are expected to work more autonomously and independently than the CTA I.
What You'll Do: 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.May assemble and distribute regulatory binders to clinical sites and provide monitors with Investigator Site File tracker in support of monitoring visits.Support project management activities including providing meeting minutes/agendas and weekly newsletter to the clinical team, as well as maintaining the clinical study tracking systems.Assist project managers in preparing study reports and collecting site status updates and study metrics.
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