Senior Clinical Research Associate

Karius

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

Posted 9/21/2026full-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 preparing monitoring reports 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 Report PreparationEnrollment TrackingQuery ManagementProtocol Deviation DocumentationCorrective Action Plan DevelopmentInspection ReadinessAdverse Event Monitoring

Soft Skills

Written CommunicationVerbal CommunicationOrganizational SkillsTime ManagementProblem-Solving

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

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

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, 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

Comp & perks

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