Clinical Research Associate

VeracyteSouth San Francisco, CA
11h$110,000 - $127,000Onsite

About The Position

The Clinical Research Associate (CRA) – Lab Clinical Operations supports the execution of Veracyte’s clinical research programs, focusing on wet lab testing for clinical studies. This role ensures clinical samples are processed, tested, and reported in compliance with GCP, CLIA/CAP regulations, study protocols, and Veracyte SOPs. Based at the San Francisco campus, the CRA partners with Clinical Affairs, Medical Affairs, and Laboratory Operations to ensure high-quality, compliant, and timely study execution.

Requirements

  • BS/BA in a scientific discipline required.
  • 3–5 years of industry-sponsored clinical research experience including laboratory operations.
  • Working knowledge of GCP and CLIA/CAP laboratory environments.
  • Strong organizational, communication, and cross-functional collaboration skills.

Nice To Haves

  • Experience in oncology biomarkers or molecular diagnostics preferred.
  • Experience with CTMS, EDC, and/or LIMS systems preferred.

Responsibilities

  • Oversee sample receipt, tracking, processing, testing, and reporting for study-specific assays.
  • Partner with the CLIA-certified laboratory to implement and monitor assay workflows.
  • Ensure laboratory activities align with study protocols and regulatory requirements.
  • Manage specimen lifecycle activities, including reconciliation and deviation resolution.
  • Support development and review of protocols, lab manuals, CRFs, and data plans.
  • Assist with study start-up, site training, and laboratory readiness.
  • Monitor laboratory data quality, turnaround times, and study metrics.
  • Work closely with Medical Affairs, Biostatistics, Data Management, Regulatory, QA, and Laboratory teams.
  • Serve as the primary contact for laboratory-related inquiries from sites and internal stakeholders.
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