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Karius is a venture-backed clinical metagenomics company developing advanced diagnostic solutions for infectious diseases using genomics and AI. The company's platform detects microbial cell-free DNA in blood to help physicians make rapid treatment decisions, identifying over 1,000 pathogens.
The Clinical Research Associate II will independently manage on-site and remote monitoring across assigned clinical research sites and studies. This role requires high autonomy in site relationship management, conducting rigorous source data verification (SDV) and source data review (SDR), and driving timely resolution of findings, queries, and protocol deviations.
Key responsibilities include:
- Independently perform monitoring visits (site qualification, initiation, interim, and closeout) in accordance with Clinical Monitoring Plans, study protocols, ICH-GCP guidelines, and regulatory requirements
- Conduct SDV/SDR to ensure Case Report Form data accuracy, completeness, and consistency with source documentation
- Manage day-to-day site relationships, including enrollment tracking, query resolution, protocol compliance, and study activity completion
- Identify and document site-level risks, protocol deviations, compliance concerns, and data discrepancies; escalate appropriately
- Prepare accurate and timely monitoring visit reports and follow-up correspondence
- Track monitoring findings and site action items through resolution
- Support development and tracking of corrective and preventive action plans (CAPAs)
- Review and maintain essential regulatory and study documents (ISFs, TMF)
- Conduct site readiness assessments and provide staff training on protocols, procedures, and specimen handling
- Support study start-up and closeout activities
- Review adverse event and serious adverse event documentation; escalate safety concerns
- Track specimen inventory, handling documentation, and chain-of-custody records
- Maintain accurate information in EDC, CTMS, and eTMF systems
- Collaborate with Clinical Trial Managers and cross-functional teams
- Serve as primary point of contact for assigned sites; may mentor less experienced CRAs
The role requires a Bachelor's degree in life sciences or health-related field, 3–5 years of clinical research monitoring experience with independent site management responsibilities, working knowledge of ICH-GCP E6(R2) guidelines, demonstrated ability to independently plan and conduct monitoring visits, proficiency with EDC/CTMS/eTMF systems, and strong written and verbal communication skills. Travel up to 60–70% is required. Reports to Sr. Manager, Clinical Site Operations.
