Clinical Trial Associate

• Assist Project Managers and study teams in conducting ophthalmic clinical studies
• Support feasibility oversight, site contracts and budgets, regulatory document collection, and follow-up patient visit scheduling
• Ensure study documentation, communication, training, and data collection comply with protocols, SOPs, regulations, and guidelines
• Draft and review study-related documents and templates
• Participate in study start-up, maintenance, and closeout activities, including Investigator Meetings
• Collect and review site regulatory documents
• Prepare essential document packages for investigational product release and site approval
• Create IRB/IEC regulatory submission packages and continuity/closeout submissions
• Assemble and distribute regulatory binders
• Order and ship study supplies to clinical sites
• Create, obtain approval for, and submit site payments to Accounting
• Support Clinical Research Associates during monitoring visits and file missing documents in the eTMF and site binder
• Support project management through meeting agendas/minutes, communications, CTMS, and study trackers
• Assist with study metric reports and site status updates
• Set up and maintain the Trial Master File/eTMF and file-sharing platforms
• Address Quality Control findings from Trial Master File audits
• Participate in Study Operations planning, risk assessments, and pre-study meetings
• Support process improvement, SOP compliance, and departmental training
• Assist with Sponsor, IRB/IEC, and FDA audit preparations
• Adhere to Ora’s quality system, data integrity, business ethics, and regulatory requirements

Clinical Trial Associate jobs in Europe

Clinical Trial Associate I