Senior Clinical Research Associate

ICON plc

Senior Clinical Research Associate overseeing oncology Phase I trials for ICON, a global clinical research organisation. Managing investigative sites, monitoring data integrity, and ensuring patient safety and inspection readiness.

Posted 8/10/2026full-timeRemote • Colorado • 🇺🇸 United StatesSenior💰 $110,520 - $138,150 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing and monitoring Oncology clinical trials, ensuring data integrity and subject safety while maintaining compliance with GxPs and regulatory standards. Proven ability to build site relationships, conduct training, and lead site engagement initiatives throughout the clinical trial lifecycle.

Highest-signal resume keywords

Oncology Clinical Trial MonitoringSolid Tumor Clinical Trial ExperienceGxP Compliance ExpertiseVeeva Systems UtilizationRisk-Based Monitoring Techniques

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MonitoringSite Management ActivitiesRegulatory Inspection SupportSite ActivationTraining Site StaffCAPA Plan DevelopmentKey Risk Indicator ReviewTMF ReconciliationDocumenting Monitoring ActivitiesRemote Monitoring Visits

Soft Skills

Relationship BuildingMentoringCollaborationProblem SolvingCommunication

Tools & Technologies

Veeva Systems

Industry Keywords

OncologyClinical TrialsGxPsIRB/Ethics CommitteePhase III TrialsRisk-Based MonitoringSite EngagementMonitoring QualityInspection ReadinessFeasibility Assessment

About the role

Key responsibilities & impact

Perform investigative site management and monitoring activities throughout the clinical trial lifecycle
Support the client's Oncology clinical trials to ensure data integrity, subject safety, and inspection readiness
Perform site management activities and maintain continuous inspection readiness
Act as the primary contact between the client's clinical trial team and sites
Perform remote and on-site monitoring/co-monitoring visits, including qualification, initiation, interim monitoring, and close-out visits
Perform oversight activities to assess monitoring quality and train or mentor less experienced CRAs
Document monitoring activities and submit or approve visit reports
Manage site essential document collection and TMF reconciliation with site files
Support local IRB/Ethics Committee submissions and confirm approvals
Review site Key Risk Indicator metrics, issues, and action items to detect trends and ensure prompt resolution
Determine root causes and develop or implement site CAPA plans
Deliver training on protocols, SOPs, GCPs, and regulations
Support sites and the client during regulatory inspections
Contribute to site identification, feasibility, qualification, and activation activities
Lead site engagement initiatives and foster relationships with key Oncology sites and networks

Requirements

What you’ll need

Bachelor's degree; scientific field preferred
5+ years monitoring clinical trials and independently conducting on-site and remote monitoring visits
At least 2 years monitoring solid tumor clinical trials
1+ years of early development oncology trial experience and/or Phase III Oncology trial experience
Solid tumor clinical trial experience required
Experience utilizing Veeva systems highly preferred
Demonstrated experience developing and maintaining site relationships and securing compliance
Expertise in GxPs and Oncology monitoring techniques, including Risk-Based Monitoring, and terminology
Experience collaborating with sites from initial engagement through close-out phases
Experience activating sites
Experience training site staff
Experience supporting sites and/or sponsors in regulatory inspections
Experience working within a Functional Services or in-house monitoring model preferred
Willingness to travel up to 50%
Legal right to work in the country where the role is based

Benefits

Comp & perks

Competitive base salary
Performance related incentives
Medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways