About the role
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, R&D, Medical Affairs, and Laboratory Operations to ensure high-quality, compliant, and timely study execution.
Key Responsibilities
Clinical & Lab Operations
- Oversee sample receipt, tracking, processing, testing, and reporting for study-specific assays.
- Partner with the R&D and CLIA-certified laboratory to implement, conduct, and monitor assay workflows.
- Ensure laboratory activities align with study protocols and regulatory requirements.
- Manage specimen lifecycle activities, including reconciliation and deviation resolution.
Study Management
- 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.
Cross-Functional Collaboration
- Work closely with R&D, Medical Affairs, Biostatistics, Data Management, Regulatory, QA, and Laboratory teams.
- Serve as the primary contact for laboratory-related inquiries from sites and internal stakeholders.
Who You Are:
- BS/BA in a scientific discipline required.
- 3-5 years of experience in medical research, laboratory, histology, IVD, nursing, or the biopharmaceutical industry
- Minimum 2 years of laboratory experience, including specimen processing and molecular assay testing
- Experience in clinical trial operations, data management, site management, or regulatory coordination preferred
- Working knowledge of GCP and CLIA/CAP laboratory environments
- Experience in oncology biomarkers or molecular diagnostics preferred
- Familiarity with CTMS, EDC, and/or LIMS systems preferred
- Strong organizational, communication, and cross-functional collaboration skills