Senior Clinical Research Associate

2 hours, 5 minutes ago
Full-time
Senior
Operations
Karius

Karius

Karius is a life sciences company revolutionizing infectious disease diagnostics with the Karius Test™, a non-invasive liquid biopsy detecting over 1000 pathogens from a single blood sample.

Pharmaceuticals
51-250
Founded 2014
$254M raised

Description

  • Perform on-site and remote monitoring visits for assigned clinical sites in accordance with the Clinical Monitoring Plan, ICH GCP guidelines, and applicable local regulations.
  • Conduct source data verification to ensure CRF data is accurate, complete, and consistent with source documents and the protocol.
  • Manage day-to-day communication with assigned sites, including support for enrollment, query resolution, and overall site performance.
  • Identify, document, and escalate site-level risks and issues through to resolution.
  • Review and maintain essential regulatory and study documents to support inspection readiness.
  • Collaborate with investigators and internal clinical teams to support study start-up, conduct, and closeout.
  • Oversee clinical trial activities in accordance with Good Clinical Practices.
  • Review monitoring reports and site data for quality trends and follow-up needs.
  • Mentor junior CRAs and share best practices when needed.

Requirements

  • Bachelor's degree in a life sciences or health-related field.
  • 5+ years of clinical trial experience, including study monitoring; 3+ years of experience with a master's degree.
  • Experience with LDTs or in vitro diagnostic devices is strongly preferred.
  • Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.
  • Ability to travel frequently, including up to 80% travel and short-notice trips.
  • Proficiency in Microsoft Office and clinical trial management systems (CTMS) preferred.
  • CCRA or CCRP certification is desired.
  • Excellent communication and interpersonal skills.
  • Strong attention to detail and advanced problem-solving skills.

Benefits

  • $91,790 - $137,684 annual salary.
  • Hybrid role in Redwood City, CA or remote work anywhere in the USA.
  • Opportunity to work on advanced diagnostics technology with direct patient impact.
  • Exposure to innovative work at the intersection of genomics, AI, and infectious disease diagnostics.
  • Equal opportunity employer with a diverse and inclusive workplace.

Interested in this position?

Apply directly on the company website

Apply Now

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