Clinical Research Associate II
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Job Description
Clinical Research Associate II monitoring diagnostic clinical studies for Karius, a genomic infectious-disease diagnostics company. Managing investigative sites, data verification, compliance, and monitoring visits.
Responsibilities:
- 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
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