Senior Clinical Research Associate

Karius

. Independently plan, conduct, and document on-site and remote monitoring visits, including SQVs, SIVs, IMVs, and COVs .

Posted 10/30/2026full-timeRemote • California • United StatesSenior💰 $91,790 - $137,684 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical monitoring, including risk-based monitoring, site management, and regulatory compliance. Proficient in managing investigative sites and mentoring junior staff while ensuring adherence to ICH-GCP guidelines and FDA regulations.

Highest-signal resume keywords

Clinical Monitoring ExperienceRisk-Based MonitoringICH-GCP E6(R2) GuidelinesEDC Systems ProficiencyACRP CCRA Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Source Data VerificationProtocol ComplianceData Quality AssessmentMonitoring Visit Reports PreparationCAPA DevelopmentEnrollment TrackingQuery ManagementSite Performance EvaluationRegulatory Document MaintenanceAdverse Event Monitoring

Soft Skills

CommunicationOrganizational SkillsTime ManagementProblem-SolvingRelationship Building

Tools & Technologies

IMediNetMedidata RaveOracle InFormVeeva Vault EDCCTMSVeeva Vault TMFGoogle WorkspaceMicrosoft Office Suite

Certifications & Qualifications

ACRP CCRASoCRA CCRP

Industry Keywords

Clinical TrialsIn Vitro DiagnosticsRegulated Medical DevicesLDTCLIAInfectious Disease StudiesMicrobiology StudiesMolecular Diagnostics

Tech Stack

Tools & technologies

OracleVault

About the role

Key responsibilities & impact

Independently 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 day-to-day investigative site relationships, enrollment, query resolution, protocol compliance, study activities, and site performance
Identify, assess, document, and escalate monitoring findings, site risks, protocol deviations, compliance concerns, and data trends
Prepare monitoring visit reports and follow-up correspondence
Track findings and action items through resolution
Maintain essential regulatory and study documents and support inspection readiness
Lead site-level study 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 subject safety, including adverse events and serious adverse events
Develop and track CAPAs and verify their effectiveness
Maintain Investigator Site Files and Trial Master File documentation
Facilitate site staff training and retraining on protocols, eClinical systems, specimen handling, and study procedures

Requirements

What you’ll need

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, enrollment tracking, query management, protocol deviations, monitoring follow-up, and risk escalation
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 monitoring visit reports
Ability to travel up to 80% of the time, including short-notice travel
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 communication, organizational, time management, problem-solving, judgment, and relationship-building abilities

Benefits

Comp & perks

Equal employment opportunities
Disability accommodation for qualified applicants