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Salary: USD 63,750 - 97,750 / annual
PathAI is transforming pathology through AI-powered technology to accelerate drug development, improve diagnostic accuracy, and deliver life-saving therapies faster. The Clinical Trial Associate (CTA) in Clinical Development Services will be a key member of the Clinical Operations team, supporting the successful execution of clinical studies with laboratory service components.
Key Responsibilities:
Study and Activity Monitoring: Bring strong understanding of Good Clinical Practice (GCP), ICH guidelines, and Code of Federal Regulations (Title 21) to support clinical trials. Oversee timely closure of queries issued to investigator sites and other parties. Work proactively with the Clinical Trial Manager (CTM) to identify performance trends and provide feedback to internal departments and clients on investigator and laboratory performance. Monitor investigator and laboratory performance, study-specific requirements, queries, pending results, and testing turnaround times. Collaborate with data management to resolve data discrepancies. Assist with specimen storage organization, tracking (receipt, retrieval, shipping), and coordinate with external vendors and sponsors on laboratory kit delivery and test result distribution.
Support to CTM: Perform routine study duties across assigned clinical trials, including receipt of site lists, drafting site-facing laboratory manuals, managing laboratory kit orders, and monitoring day-to-day trial operations (specimen management reports, case assignments on PathAI AISight CT Platform, pending lab analysis). Support CTM with administrative tasks (action item tracking, meeting minutes, process mapping). Act as backup support during CTM absence, including leading client communication and study management activities.
Proactive Communication: Interact with functional areas and vendors to resolve problems and enhance service delivery. Liaise with Laboratory, Engineering, and other departments to expedite specimen testing and kit provision. Coordinate site-level information and communications, identifying and escalating discrepancies. Assist with development of meeting and training materials.
Project Documentation: Assist in reviewing study startup deliverable schedules, milestones, and tasks. Maintain project documentation files. Oversee and lead project close-out procedures. Perform administrative and process-related duties as needed.
Requirements:
Required: 3+ years of clinical research experience in medical device and/or drug development clinical trials. Bachelor's degree (BS or BA) in a relevant scientific discipline. Strong organizational skills, attention to detail, and ability to multitask.
Preferred: Experience in digital pathology, radiology, or other imaging technology-based clinical trials. Project Management Certification.
