Clinical Trial Associate

• Monitor clinical trial lab services and engage with clinical investigator sites
• Support the primary Clinical Trial Manager (CTM)
• Apply knowledge of GCP, ICH, regulatory requirements, and Title 21 of the Code of Federal Regulations
• Oversee timely closure of queries issued to investigator sites and designated parties
• Identify trends and provide feedback on Investigator and PathAI BioPharma Laboratory performance
• Monitor investigators, laboratory performance, study requirements, queries, pending results, and testing turnaround times
• Collaborate with data management to resolve data discrepancies
• Organize and track storage specimens, including receipt, retrieval, and shipping
• Coordinate with external vendors and sponsors to deliver laboratory kits and test results
• Perform routine study duties, including site lists, laboratory manuals, laboratory kit orders, specimen management reports, case assignments on the PathAI AISight CT Platform, and pending lab analysis
• Support CTM administrative tasks, including action item tracking, meeting minutes, and process mapping
• Provide backup CTM support, including client communication and study management
• Collaborate with functional areas, vendors, Laboratory, Engineering, and support services
• Coordinate site-level project information and escalate discrepancies
• Assist with meeting and training materials
• Support study start-up deliverables, milestones, project documentation, and close-out procedures
• Perform other administrative or process-related duties as needed

• Ensure vendor spreadsheets are completed correctly and processed according to study team guidelines
• Submit vendor spreadsheets to the vendor or global team
• Attend weekly Study Team meetings and report on vendor spreadsheets
• Participate in vendor management activities
• Work in a sponsor-dedicated model supported by ICON’s global expertise

Clinical Trial Associate – Study Start-Up Support

• Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout
• Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations
• Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams
• Set up, organize and maintain study files and shared spaces in accordance with study requirements
• Coordinate and track study training
• Manage study sample and supply tracking and support interactions with vendors as needed
• Support the Study Management team with specific projects
• Communicate with study team members and identify and address study-related issues in collaboration with the study team
• Perform routine quality checks on trial-level documents to ensure completeness and accuracy
• Support timely, complete and compliant archiving in the TMF
• Participate in company, departmental and project team meetings, including Investigator Meetings
• Assist with basic financial and budget tracking activities related to the clinical trial

Clinical Trial Associate, Senior Project Specialist

• 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

• Monitor clinical supply inventory levels, trends, and potential supply risks
• Support supply forecasting, metrics reporting, and inventory tracking activities
• Process requisitions and coordinate procurement of comparator drugs and ancillary supplies
• Coordinate clinical supply shipments, depot transfers, and site return logistics
• Track shipment delivery schedules and assist with temperature excursion investigations and resolution
• Maintain study documentation, including Expected Document Lists (EDLs), comparator records, and Electronic Trial Master File (eTMF) documentation
• Support QA/QP release requests, inspection readiness activities, and pack-and-label reconciliation processes
• Assist with Interactive Response Technology (IRT) activities, including user access management, alert monitoring, and User Acceptance Testing (UAT)
• Conduct product compatibility research and maintain related data in approved databases and tracking tools
• Manage clinical supply system records, shared mailboxes, and documentation uploads within Veeva
• Perform administrative and support activities assigned by the Clinical Trial Supplies Manager or Project Lead
• Operate independently with minimal day-to-day oversight and may coordinate activities of other Clinical Trial Supplies Associates

Senior Clinical Trial Supplies Associate

• Support Clinical Operations and project teams across all phases of clinical projects
• Interact with Clinical teams, site staff, and vendors in the U.S. and worldwide to support project-specific tasks and overall clinical trial management
• Maintain and manage study-system user access and deactivation requests
• Coordinate materials for internal and external meetings
• Distribute safety alerts and relevant documents as required
• Maintain study-team and vendor contact information
• Assist with planning, organizing, and executing study-specific meetings; write and distribute agendas, minutes, and updates
• Review, format, and finalize study-related templates, plans, and manuals as needed
• Assist with maintaining clinical trial insurance
• Route Clinical Research Organization/study-team questions and requests for resolution
• Participate in clinical data review as required
• Maintain complete Trial Master File documentation and conduct ongoing quality and SOP/ICH-GCP compliance reviews
• Route, track, and file Clinical documents
• Review site Clinical regulatory documentation for completeness and dates as needed
• Develop and maintain study-related trackers and analyze or update tracker data
• Support Study Team Leads and Operational Team Leads with other assigned duties

Senior Clinical Trial Associate – Sr. CTA

• Support day-to-day clinical study activities, including inspection readiness and oversight of inspection deliverables and milestones
• Collaborate with Clinical Trial Managers, study teams, vendors, and CROs on clinical study activities
• Prepare and coordinate bi-weekly clinical trial team meetings and track action items
• Develop, review, and approve study documentation and essential document packets
• Contribute to clinical documents including protocols, informed consent forms, investigator brochures, trial reports, ASRs/DSURs, laboratory manuals, pharmacy manuals, and trial status updates
• Ensure clinical trial documentation and the trial master file remain audit-ready
• Track patient samples and reconcile discrepancies with sites and central labs
• Assist with invoices, clinical projections, and per-patient cost estimates
• Support study and site start-up activities, including SIV slides, process flows, contract and budget negotiations, site ICF customizations, and IRB questions
• Review clinical monitoring visit reports and ensure follow-up items are closed
• Collaborate with Legal, Finance, Nonclinical, CROs, and external vendors
• Maintain trial-related processes and systems with study vendors
• Develop and drive timelines for data cuts, conference needs, and interim analyses
• Monitor and report clinical trial progress, budgets, and timelines
• Maintain patient trackers and follow up on outstanding patient visits
• Initiate ClinicalTrials.gov updates and publications
• Participate in preparing and reviewing SOPs
• Perform other business needs identified by the direct line manager