Karius
Karius
Karius is a biotechnology company focused on infectious disease diagnostics. Its clinical metagenomics platform combines genomic analysis with artificial intelligence to identify microbial cell-free DNA released by pathogens into the bloodstream. The Karius Test is a liquid biopsy designed to help clinicians detect more than 1,000 pathogens and gain broader diagnostic insight, including when evaluating infections in immunocompromised patients. The company’s work centers on making infectious disease diagnosis more comprehensive and timely through advanced laboratory and computational methods.

Senior Clinical Research Associate – California Remote

Karius is seeking a Senior Clinical Research Associate to oversee clinical sites supporting genomic and AI-enabled infectious disease diagnostics. The role covers risk-based monitoring, regulatory compliance, site performance, and clinical team mentorship.

Description

  • Plan, conduct, and document on-site and remote monitoring visits, including SQV, SIV, IMV, and COV visits
  • Use risk-based monitoring to assess site performance, protocol adherence, data quality, participant safety, and documentation completeness
  • Perform source data verification and source data review
  • Oversee site relationships, enrollment, query resolution, protocol compliance, study milestones, and site performance
  • Document monitoring findings, site risks, protocol deviations, compliance issues, and data trends, escalating concerns with corrective actions
  • Draft monitoring visit reports and related follow-up correspondence
  • Track findings and action items through closure and confirm that resolutions are effective
  • Maintain essential regulatory and study records to support inspection readiness
  • Direct site initiation and closeout activities
  • Partner with Clinical Trial Managers and cross-functional teams on monitoring observations and risk evaluations
  • Coach and support junior CRAs and CTAs
  • Review adverse events and serious adverse events, escalating potential safety concerns
  • Create and validate corrective and preventive action plans
  • Maintain Investigator Site Files and Trial Master File records
  • Support site personnel training and retraining on protocols, eClinical systems, specimen handling, and study procedures

Requirements

  • Bachelor’s degree in life sciences or a health-related discipline, or an equivalent combination of education and experience
  • Five to eight years of clinical monitoring experience, including independent on-site and remote monitoring across multicenter studies
  • Experience monitoring diagnostic, in vitro diagnostic, or regulated medical device studies
  • Working knowledge of ICH-GCP E6(R2) and FDA requirements, including 21 CFR Parts 11, 50, 54, 56, 312, and 812
  • Understanding of risk-based monitoring frameworks and centralized monitoring approaches
  • Ability to independently manage investigative sites, including enrollment tracking, query oversight, protocol deviation documentation, monitoring follow-up, and escalation of site risks
  • Proficiency with EDC platforms such as iMediNet, Medidata Rave, Oracle InForm, or Veeva Vault EDC, as well as CTMS and eTMF systems such as Veeva Vault TMF or Complion
  • Proficiency in Microsoft Office and Google Workspace
  • Experience producing accurate, high-quality monitoring visit reports
  • Ability to travel up to 80% of the time, including with limited notice
  • ACRP CCRA or SoCRA CCRP certification is preferred
  • Experience monitoring infectious disease, microbiology, molecular diagnostics, or related clinical research is preferred
  • Experience mentoring or training junior CRAs is preferred
  • Familiarity with LDT and CLIA regulatory requirements is preferred
  • Strong written and verbal communication, organization, time management, problem-solving, judgment, and relationship-building abilities

Benefits

  • Karius provides equal employment opportunity and supports diversity and inclusion
  • Disability accommodations are available for qualified applicants

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