PathAI · 1 day ago
Clinical Trial Associate
PathAI is on a mission to improve patient outcomes with AI-powered pathology. The Clinical Trial Associate will play a vital role in the Clinical Operations team, ensuring successful completion of clinical studies with a lab services component.
BiotechnologyHealth CareHealth Diagnostics
Responsibilities
Bring a strong understanding of GCP, ICH, and knowledge of regulatory requirements in support of successful clinical trials
Adhere to the Code of Federal Regulations (Title 21) and guidelines set up by the International Committee for Harmonization (ICH) for good clinical practices
Oversee and manage the timely closure of queries issued to clinical trial investigator sites and/or other designated parties
Work with the CTM to proactively identify trends and provide feedback to internal departments and/or clients on performance of both the Investigator and the PathAI BioPharma Laboratory to ensure timely service delivery
Monitor the performance of both the Investigator(s) and/or the Laboratory as applicable
Monitor study specific and/or Sponsor requested requirements
Oversee and/or monitor queries, pending results, testing TATs, etc
Collaborate with data management to ensure resolution of data discrepancies at all stages of the study
Assist with the organization and tracking of storage specimens: receipt, retrieval, and shipping as applicable
Coordinate with external vendors and Sponsors to ensure delivery of laboratory kits and test results to sites
Perform generic, routine study duties and tasks that are applicable across assigned clinical trials, including but not limited to: receipt of site lists, drafting of site facing laboratory manuals, managing laboratory kits orders, and monitoring the day-to-day trial operations (i.e., specimen management reports, case assignments on the PathAI AISight CT Platform, monitoring pending lab analysis, etc.)
Support the CTM for routine administrative tasks of the clinical trial (e.g., action item tracking, meeting minutes, process mapping, etc.)
Act as a backup support for the CTM during their times of absence, including leading client communication and study management activities
Interact with other functional areas and/or vendors to resolve problems, enhance processes, and service delivery
Liaise with other departments and support services (e.g., Laboratory, Engineering, etc) to expedite testing of patient’s laboratory specimens and/or provision of kits
Coordinate information and communications for designated projects at the site level, including identification and escalation of discrepancies as needed
Assist with the development of meeting or training materials where applicable
Assist in reviewing study start up project deliverable schedule, milestones and required tasks
Support maintenance of project documentation files
Oversee and/or lead Project Close-out procedures as required
Assist with the development of meeting or training materials where applicable
Perform other administrative or process-related duties as needed to support the success of the trial
Qualification
Required
3+ years of clinical research experience in medical device and/or drug development clinical trials
BS or BA in a relevant scientific discipline
Strong understanding of GCP, ICH, and knowledge of regulatory requirements in support of successful clinical trials
Adhere to the Code of Federal Regulations (Title 21) and guidelines set up by the International Committee for Harmonization (ICH) for good clinical practices
Good organizational skills, attention to details, and ability to multitask
Preferred
Experience in digital pathology, radiology or other imaging technology-based clinical trials
Project Management Certification is a plus
Benefits
Eligible for Equity
Company
PathAI
PathAI develops technology that assists pathologists in making accurate diagnoses for every patient, every time.
H1B Sponsorship
PathAI has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (20)
2023 (21)
2022 (29)
2021 (25)
2020 (7)
Funding
Current Stage
Late StageTotal Funding
$355.2MKey Investors
LabCorpGeneral AtlanticGeneral Catalyst
2024-05-01Acquired
2022-01-01Debt Financing· $100M
2021-05-18Series C· $165M
Recent News
2025-12-10
GlobeNewswire
2025-12-08
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