Clinical Research Associate II

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $83.5k - $125.2k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Perform independent on-site and remote monitoring visits, including SQVs, SIVs, IMVs, and COVs • Conduct source data verification and source data review • Manage relationships with assigned investigative sites, including enrollment, queries, protocol compliance, and study activities • Identify and document site-level risks, protocol deviations, compliance concerns, and data discrepancies • Prepare monitoring visit reports and follow-up correspondence • Track monitoring findings, site action items, and outstanding issues through resolution • Support corrective and preventive action plans following protocol deviations or compliance concerns • Maintain essential regulatory and study documents, ISFs, and TMF completeness • Conduct site readiness assessments and train site staff on protocols, procedures, systems, and specimen handling • Support study start-up, site activation, closeout, reconciliation, and required documentation • Review AE and SAE documentation and escalate discrepancies or safety concerns • Track and reconcile specimen kit inventory, handling documentation, and chain-of-custody records • Maintain information across EDC, CTMS, and eTMF systems • Collaborate with Clinical Trial Managers and cross-functional study teams • Serve as primary day-to-day contact for assigned sites and provide guidance to less experienced CRAs or CTAs

🎯 Requirements

• Bachelor's degree in a life sciences or health-related field, or equivalent combination of education and experience • Three to five years of clinical research monitoring experience, including independent site management responsibilities • Working knowledge of ICH-GCP E6(R2) guidelines and applicable clinical research regulations • Ability to independently plan, conduct, and report on on-site and remote monitoring visits • Proficiency with EDC, CTMS, and eTMF systems • Strong written and verbal communication skills • Ability to identify, escalate, and help resolve site-level risks and compliance issues • Strong organizational skills and ability to manage multiple sites and competing priorities • Valid driver's license required • Preferred: Experience monitoring diagnostic, IVD, or molecular biology clinical studies • Preferred: ACRP (CCRA) or SoCRA (CCRP) certification, or active progress toward certification • Preferred: Experience mentoring or supporting the onboarding of junior CRAs

🏖️ Benefits

• Equal employment opportunities • Disability accommodations for qualified individuals