About this role
About Karius
Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases.
Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.
Position Summary
The Sr. Clinical Research Associate is responsible for advanced clinical site management and monitoring across Karius clinical programs, ensuring adherence to study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements. Building on the full independent site ownership expected of a CRA II, the Sr.
CRA manages more complex or higher-risk sites, applies advanced judgment to monitoring findings and emerging risks, and recommends corrective actions to support effective study execution. The Sr. CRA partners closely with Clinical Trial Managers and cross-functional teams and serves as a resource and mentor to less experienced Clinical Operations team members.
Why Should You Join Us?
Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients.
Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
Reports to: Sr. Manager, Clinical Site Operations
Location: Remote
Primary Responsibilities
Independently plan, conduct, and document on-site and remote monitoring visits, including site qualification visits (SQVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and closeout visits (COVs), in accordance with the Clinical Monitoring Plan, study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements.
Apply a risk-based monitoring approach to evaluate site performance, protocol compliance, data quality, subject safety, and documentation completeness, and determine appropriate follow-up actions.
Conduct comprehensive source data verification (SDV) and source data review (SDR) to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documentation and the study protocol.
Independently manage day-to-day site relationships, driving enrollment momentum, query resolution, protocol compliance, timely completion of study activities, and overall site performance.
Proactively identify, assess, and document monitoring findings, site-level risks, protocol deviations, compliance concerns, and data trends, and escalate significant or recurring issues with recommended corrective actions.
Prepare and submit timely, high-quality monitoring visit reports and follow-up correspondence that clearly document site health, compliance status, findings, risks, required actions, and follow-up expectations.
Track monitoring findings and action items through resolution and verify completion and effectiveness during subsequent monitoring contacts.
Oversee the collection, review, and maintenance of essential regulatory and study documents to support ongoing inspection readiness.
Support and lead site-level study start-up activities, including site qualification, readiness assessments, SIVs, regulatory document collection, and site activation requirements.
Support and lead site-level closeout activities, including COVs, resolution of outstanding queries and monitoring findings, reconciliation activities, and completion of required site documentation.
Collaborate closely with Clinical Trial Managers and cross-functional partners to provide site-level monitoring insights, risk assessments, and recommendations that inform study planning and operational decision-making.
Mentor junior CRAs and CTAs on monitoring standards, visit preparation and execution, documentation practices, site management, and issue resolution.
Monitor subject safety throughout the study, including timely review and assessment of adverse events (AEs) and serious adverse events (SAEs), and promptly escalate safety signals or reporting concerns in accordance with sponsor and regulatory requirements.
Develop, track, and confirm implementation of corrective and preventive action plans (CAPAs) with investigative sites following protocol deviations, compliance concerns, or recurring performance issues, and verify effectiveness during subsequent monitoring visits.
Evaluate and maintain Investigator Site Files (ISFs) and Trial Master File (TMF) documentation in accordance with sponsor SOPs, the TMF Reference Model, and study requirements, proactively identifying and resolving documentation gaps.
Facilitate and support site staff training and retraining on protocol requirements, eClinical systems, specimen collection and handling, and study-specific procedures throughout study conduct.
What’s Fun About the Job?
Karius is operating at the edge of what is now known to be possible in diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.
Travel: Travel required up to 80%.
Physical Requirements
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment.
Position Requirements
Bachelor's degree in a life sciences or health-related field, or equivalent combination of education and experience.
5-8 years of clinical monitoring experience, including independent on-site and remote monitoring across multi-site studies.
Experience monitoring studies for diagnostics, in vitro diagnostics (IVD), or regulated medical device products; familiarity with FDA device regulatory pathways strongly preferred.
Strong working knowledge of ICH-GCP E6(R2) guidelines, FDA regulations, including 21 CFR Parts 11, 50, 54, 56, 312, and 812, and applicable local requirements governing clinical research.
Familiarity with risk-based monitoring (RBM) frameworks and central monitoring methodologies.
Demonstrated ability to independently manage a portfolio of investigative sites, including enrollment tracking, query management, protocol deviation documentation, monitoring follow-up, and appropriate escalation of site-level risks.
Proficiency with electronic data capture (EDC) systems, such as iMediNet, Medidata Rave, Oracle InForm, or Veeva Vault EDC; clinical trial management systems (CTMS); and eTMF platforms, such as Veeva Vault TMF or Complion.
Proficiency with Microsoft Office Suite and Google Workspace, including Docs, Sheets, Slides, Gmail, and Drive.
Demonstrated experience preparing clear, accurate, and high-quality monitoring visit reports with actionable findings and follow-up requirements.
Strong written and verbal communication skills, including the ability to prepare concise monitoring reports, professional site correspondence, and clear study updates.
Demonstrated ability to build and sustain effective working relationships with investigative sites, Clinical Trial Managers, and cross-functional