Senior Clinical Research Associate

Job not on LinkedIn

🔥 25 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $91.8k - $137.7k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Karius

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Karius is a biotechnology company specializing in infectious disease diagnostics. The company uses genomics and artificial intelligence to detect microbial cell-free DNA from pathogens in the bloodstream, enabling the identification of over 1000 pathogens causing infections. Karius aims to transform infectious disease diagnosis with the help of clinical metagenomics, providing clear and timely diagnostic results. Their innovative Karius Test is a novel liquid biopsy designed to provide clinicians with comprehensive diagnostic insights into infections, even in immunocompromised patients.

📋 Description

• Plan, conduct, and document on-site and remote monitoring visits, including SQVs, SIVs, IMVs, and COVs • Apply risk-based monitoring to evaluate site performance, protocol compliance, data quality, subject safety, and documentation completeness • Conduct source data verification and source data review • Manage site relationships, enrollment, query resolution, protocol compliance, study timelines, and site performance • Identify and document monitoring findings, site risks, protocol deviations, compliance concerns, and data trends; escalate issues with corrective actions • Prepare monitoring visit reports and follow-up correspondence • Track findings and action items through resolution and verify effectiveness • Maintain essential regulatory and study documents for inspection readiness • Lead site start-up and closeout activities • Collaborate with Clinical Trial Managers and cross-functional partners on monitoring insights and risk assessments • Mentor junior CRAs and CTAs • Monitor adverse events and serious adverse events and escalate safety concerns • Develop and verify corrective and preventive action plans • Maintain Investigator Site Files and Trial Master File documentation • Support site staff training and retraining on protocols, eClinical systems, specimen handling, and study procedures

🎯 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 diagnostics, in vitro diagnostics (IVD), or regulated medical device studies • Strong working knowledge of ICH-GCP E6(R2) guidelines and FDA regulations, including 21 CFR Parts 11, 50, 54, 56, 312, and 812 • Familiarity with risk-based monitoring frameworks and central monitoring methodologies • Ability to independently manage investigative sites, including enrollment tracking, query management, protocol deviation documentation, monitoring follow-up, and escalation of site-level risks • Proficiency with EDC systems such as iMediNet, Medidata Rave, Oracle InForm, or Veeva Vault EDC; CTMS; and eTMF platforms such as Veeva Vault TMF or Complion • Proficiency with Microsoft Office Suite and Google Workspace • Experience preparing high-quality monitoring visit reports • Ability to travel up to 80% of the time, including on short notice • ACRP CCRA or SoCRA CCRP certification preferred • Experience monitoring infectious disease, microbiology, molecular diagnostics, or related clinical studies preferred • Experience mentoring or training junior CRAs preferred • Familiarity with LDT and CLIA regulatory frameworks preferred • Strong written and verbal communication, organizational, time management, problem-solving, judgment, and relationship-building skills

🏖️ Benefits

• Equal employment opportunities and commitment to diversity and inclusion • Disability accommodations for qualified applicants