Clinical Trial Associate
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Job Description
Clinical Trial Associate supporting clinical operations for PathAI’s AI-powered pathology trials. Monitoring lab services, investigator sites, specimens, and CTM deliverables.
Responsibilities:
- 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
Requirements:
- 3+ years of clinical research experience in medical device and/or drug development clinical trials
- BS or BA in a relevant scientific discipline
- Good organizational skills
- Attention to detail
- Ability to multitask
- Experience in digital pathology, radiology or other imaging technology-based clinical trials is highly preferred
- Project Management Certification is a plus
Benefits:
- Remote work option
- Relocation benefits are not available for this position
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