Clinical Trial Associate
About Karius
Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.
Position Summary:
The Clinical Trial Associate (CTA) supports CRAs, and study teams across Karius clinical studies by assisting with the collection, quality control, and quality assurance of study and trial related regulatory documentation, and by helping to set up and maintain the Trial Master File (TMF) in accordance with ICH-GCP and applicable regulatory requirements. The CTA helps ensure that study and trial related regulatory documents are collected and filed accurately, supports identification of gaps in the TMF, and helps communicate with sites and study teams to obtain outstanding documents. The CTA works under the guidance of the study team while building proficiency with TMF standards and documentation practices.
Why Should You Join Us?
Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company's platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
Reports to: Sr. Manager, Clinical Site Operations
Location: Remote (Bay Area preferred)
Primary Responsibilities:
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Assist study teams with the collection, quality control (QC), and quality assurance (QA) of study and trial-related regulatory documents.
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Support the setup and maintenance of the Trial Master File (TMF) in accordance with sponsor SOPs, the TMF Reference Model, and applicable regulatory requirements, including ICH-GCP.
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Help ensure study and trial-related regulatory documents are collected, reviewed, filed, and maintained accurately and in a timely manner within the TMF.
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Perform routine QC and QA reviews of TMF documentation under guidance to confirm completeness, accuracy, and appropriate filing.
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Assist in identifying gaps in the TMF and tracking outstanding or missing documents across assigned studies through resolution.
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Communicate with clinical sites and study teams, under guidance, to request and follow up on outstanding or missing regulatory documents.
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Support the maintenance of Investigator Site Files (ISFs) in coordination with site staff and study teams.
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Assist with the development and maintenance of study templates, trackers, forms, and other study tools.
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Maintain study trackers, documentation, and shared study materials using Google Workspace tools, including Google Sheets, Docs, and Drive.
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Assist with the preparation and organization of TMF and ISF documentation for audits and inspections.
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Support investigator meeting planning, coordination, and logistics, including preparation of meeting materials and follow-up activities.
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Maintain study communication and distribution lists to support timely and accurate communication with study teams and clinical sites.
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Support study start-up activities, including the collection and t