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Clinical Trial Associate – Massachusetts Remote
Support clinical operations for PathAI’s AI-powered pathology trials as a Clinical Trial Associate. Coordinate laboratory services, investigator sites, specimens, and Clinical Trial Manager deliverables.
विवरण
- Monitor clinical trial laboratory services and coordinate with clinical investigator sites
- Support the lead Clinical Trial Manager (CTM)
- Apply working knowledge of GCP, ICH guidelines, regulatory requirements, and Title 21 of the Code of Federal Regulations
- Track and drive the timely resolution of queries assigned to investigator sites and other designated parties
- Analyze performance trends and provide feedback on investigator sites and the PathAI BioPharma Laboratory
- Monitor investigators, laboratory performance, study requirements, queries, pending results, and testing turnaround times
- Partner with data management to investigate and resolve data discrepancies
- Organize and track stored specimens, including receipt, retrieval, and shipment
- Coordinate with external vendors and sponsors on laboratory kit delivery and test results
- Manage routine study activities, including site lists, laboratory manuals, kit orders, specimen reports, PathAI AISight CT Platform case assignments, and pending laboratory analyses
- Assist with CTM administration, including action tracking, meeting minutes, and process mapping
- Provide backup CTM coverage for client communications and study management activities
- Work with cross-functional teams, vendors, Laboratory, Engineering, and support services
- Coordinate site-level project information and escalate discrepancies
- Help prepare meeting and training materials
- Support study start-up deliverables, milestones, project records, and close-out activities
- Complete additional administrative and process-related duties as required
आवश्यकताएँ
- At least three years of clinical research experience in medical device and/or pharmaceutical clinical trials
- Bachelor’s degree in a relevant scientific field
- Strong organizational abilities
- High attention to detail
- Ability to manage multiple tasks simultaneously
- Experience with digital pathology, radiology, or other imaging technology-based clinical trials is strongly preferred
- Project management certification is a plus
लाभ
- Remote work option
- Relocation benefits are not available for this position
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