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

• 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