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 I

• Assist Project Managers and study teams with clinical study conduct for ophthalmic projects
• Support study feasibility, site contracts and budgets, regulatory document collection, follow-up patient visit scheduling, and GCP protocol compliance
• Ensure study documentation, communication, training, and data collection align with protocols, SOPs, regulations, and guidelines
• Lead development of study-related documents, including informed consent forms, source documents, and study logs
• Participate in clinical trial site management from study start-up through study conduct and closeout
• Collect and review site regulatory documents for accuracy and completeness
• Prepare essential document packages for investigational product release, site approval, continuity reports, and closeout submissions
• Create regulatory packages for IRB/IEC study and site submissions
• Assemble and distribute regulatory binders and provide Investigator Site File trackers for monitoring visits
• Support project management through meeting minutes, agendas, weekly newsletters, and clinical study tracking systems
• Assist with study reports, site status updates, and study metrics
• Set up, maintain, and quality-control Trial Master Files/electronic Trial Master Files and file-sharing platforms
• Participate in Study Operations planning, risk assessment discussions, and pre-study meetings
• Support process improvement, SOP reviews, and departmental training
• Assist with audit preparation and responses to audit findings
• Adhere to Ora's quality system, data integrity, business ethics, and regulatory requirements

Clinical Trial Associate II

Associate

• Facilitate the review and execution process for Clinical Trial Agreements (CTAs) and amendments with sponsors, sites, and Ora legal teams
• Support development, review, and negotiation of clinical trial budgets, including per-patient costs, start-up fees, pass-through expenses, and overhead
• Track contract milestones, renewals, and amendments throughout the study lifecycle
• Monitor budget approvals and align contract terms with negotiated budgets
• Ensure payment terms, invoicing schedules, and milestone payments are clearly defined in contracts
• Analyze study protocols for cost implications and ensure budgets reflect fair market value (FMV)
• Prepare reports for study teams regarding contract status, budget approvals, and payment status
• Collaborate with global cross-functional project teams, including Project Management, Clinical Trial Associates, Clinical Research Associates, Project Directors, and IT
• Collaborate with Legal on contract negotiations
• Identify, track, and monitor data integration between EDC and Veeva Vault systems; highlight and follow up on issues causing payment delays
• Set up, process, and manage clinical trial site payments in the Veeva Vault Payment system according to CTAs and approved budgets
• Verify payment triggers are met before payment
• Calculate and reconcile per-patient payments, start-up fees, milestone payments, and pass-through expenses
• Ensure payments are issued accurately and on schedule
• Reconcile payments with invoices, supporting documentation, and financial systems
• Identify and resolve overpayments, underpayments, and payment discrepancies
• Adhere to Ora’s quality system and required compliance, data integrity, business ethics, and regulatory processes
• Demonstrate Ora’s values of kindness, operational excellence, cultivating joy, and scientific rigor

Clinical Trial Associate I

Clinical Trial Associate II

Site Contract and Payment Associate