Senior Clinical Research Associate (Temp) Karius - Redwood City, CA, US Onsite​/Remote

Senior Clinical Research Associate (Temp)

Karius

Redwood City, CA, US / Onsite/Remote

Job Type: Full-Time

Function:
Clinical Research

Industry: Health Tech

About Karius

Karius sees a world where infectious disease is no longer a major threat to human health. To achieve this, the Karius Test uses genomics and AI to map a patient's microbial landscape from a single blood sample to enable clinicians to make rapid treatment decisions.

Job Description

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 Senior Clinical Research Associate is responsible for clinical site management and monitoring activities to ensure adherence to study protocols, GCP guidelines, and applicable regulations. This role performs on site and remote monitoring, reviews monitoring reports and site data for quality and trends, supports issue identification and resolution at the site level, and collaborates closely with the clinical study team.

The Senior CRA may mentor junior CRAs, sharing best practices to support high quality monitoring and successful execution of clinical trials. This is a temporary position: 6 months 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 orts to:
Sr. Manager, Clinical Site Operations

Location:

Redwood City, CA (Hybrid) or Remote (USA) Primary Responsibilities
• Perform on-site and remote monitoring visits for assigned sites in accordance with the Clinical Monitoring Plan, ICH GCP guidelines, and applicable local regulations.
• Conduct source data verification to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documents and the protocol.
• Manage day-to-day communication with assigned sites, supporting enrollment, query resolution, and overall site performance.
• Proactively identify and document site level risks and issues, respond to study specific questions, and manage escalations through to resolution.
• Oversee the collection, review, and maintenance of essential regulatory and study documents to ensure inspection readiness.
• Collaborate closely with investigators and internal clinical teams to support effective study start up, conduct, and close out and to ensure successful trial execution.
• Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. 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…