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Clinical Trial Associate

1 hour, 34 minutes ago
United States
Full-time
Junior
Project Coordinator
Project and Program Management
Machine Learning
Apply Now
Karius

Karius

Karius is a life sciences company revolutionizing infectious disease diagnostics with the Karius Test™, a non-invasive liquid biopsy detecting over 1000 pathogens from a single blood sample.

Pharmaceuticals
51-250
Founded 2014
$254M raised
View All Jobs 4

Description

  • Assist study teams with collection, QC, and QA of regulatory documents.
  • Support setup and maintenance of the Trial Master File (TMF) in line with sponsor SOPs, the TMF Reference Model, and ICH-GCP requirements.
  • Ensure study documents are collected, reviewed, filed, and maintained accurately and on time.
  • Perform routine TMF documentation reviews to confirm completeness, accuracy, and proper filing.
  • Identify TMF gaps and track outstanding or missing documents through resolution.
  • Communicate with clinical sites and study teams to request and follow up on missing documents.
  • Support maintenance of Investigator Site Files (ISFs) with site staff and study teams.
  • Assist with study templates, trackers, forms, and shared study materials using Google Workspace.
  • Prepare and organize TMF and ISF documentation for audits and inspections.
  • Support investigator meeting planning, study start-up, study closeout, document archiving, and general administrative support for clinical study teams.

Requirements

  • Bachelor's degree in life sciences, health sciences, clinical research, or a related field, or equivalent education and experience.
  • 1-3 years of experience in clinical research, clinical operations, regulatory documentation, or a related environment.
  • Basic understanding of clinical research processes and compliant clinical trial documentation.
  • Familiarity with Trial Master Files (TMFs), Investigator Site Files (ISFs), or the ability to quickly learn these systems.
  • Basic knowledge of ICH-GCP, FDA regulations, and other clinical research requirements; familiarity with ISO standards and CLIA requirements is a plus.
  • Familiarity with medical and clinical research terminology, or the ability to learn technical terminology quickly.
  • Strong attention to detail and ability to identify incomplete or missing information.
  • Strong organizational and time management skills with the ability to manage multiple tasks and meet timelines.
  • Strong written and verbal communication skills for working with CRAs, study teams, and sites.
  • Ability to follow procedures, incorporate feedback, and work under guidance while building independence.
  • Demonstrated accountability, reliability, and follow-through.
  • Proficiency with Microsoft Office Suite and Google Workspace.
  • Ability to work in a collaborative, fast-paced environment while maintaining accuracy and confidentiality.
  • Preferred: Exposure to clinical studies in infectious disease, microbiology, molecular diagnostics, genomics, or related life sciences.
  • Preferred: Familiarity with electronic Trial Master File (eTMF) platforms.

Benefits

  • Remote work with Bay Area preferred.
  • Travel required up to 10-20%.
  • Opportunity to contribute to improving patient care and infectious disease diagnostics.
  • Work on advanced genomic sequencing, machine learning, and clinical diagnostics technologies.

Interested in this position?

Apply directly on the company website

Apply Now

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