Clinical Research Associate II (East Coast or Midwest

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.

The CRA II performs independent on site and remote monitoring across assigned sites and studies within Karius' diagnostic clinical programs. This role manages site relationships with a high degree of autonomy, conducts rigorous source data verification (SDV) and source data review (SDR), and drives timely resolution of findings, queries, and protocol deviations. The CRA II is a dependable operational contributor who proactively identifies risks and escalates issues with appropriate recommendations, while maintaining inspection ready documentation.

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 (East or Midwest Area)

• Independently perform on-site and remote monitoring visits for assigned sites, 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.

• Conduct 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 study requirements.

• Manage day-to-day relationships with assigned investigative sites, including enrollment progress, query resolution, protocol compliance, and completion of study activities.

• Identify and document site-level risks, protocol deviations, compliance concerns, and data discrepancies, and elevate issues appropriately.

• Prepare and submit accurate and timely monitoring visit reports and follow-up correspondence documenting site status, findings, and required actions.

• Track monitoring findings, site action items, and outstanding issues through resolution.

• Support the development and tracking of corrective and preventive action plans (CAPAs) following protocol deviations or compliance concerns.

• Review and maintain essential regulatory and study documents, including Investigator Site Files (ISFs), and support Trial Master File (TMF) completeness and inspection readiness.

• Conduct site readiness assessments and provide site staff training on study protocols, procedures, systems, and specimen collection and handling requirements.

• Support study start-up and closeout activities, including site activation, outstanding query resolution, reconciliation, and completion of required documentation.

• Review adverse event (AE) and serious adverse event (SAE) documentation and raise discrepancies or potential safety concerns in accordance with study requirements.

• Track and reconcile specimen collection kit inventory, specimen handling documentation, and chain-of-custody records.

• Maintain accurate and timely…