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kariusdx - Senior Clinical Research Associate (Temp)

Redwood City, CA (Hybrid) or Remote (USA) - Hybrid3d ago

In Office Senior NA Clinical Research Cloud Computing Associate Senior Researcher Documentation Reporting GCP Close

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. • This position requires excellent communication and interpersonal skills, attention to detail, and advanced problem solving.

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.

Benefits

• 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: Redwood City, CA (Hybrid) or Remote (USA)