Clinical Research Associate

ICON plc

. Work on multiple trials across cross-therapeutic areas with a start-up focus .

Posted 11/4/2026full-timeRemote • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trial start-up activities, ensuring compliance with ICH-GCP guidelines and local regulatory standards. Proficient in coordinating site selection, regulatory approvals, and maintaining documentation for inspection readiness.

Highest-signal resume keywords

Clinical Trial MonitoringStudy Start-Up ExperienceGood Clinical Practice (GCP)Regulatory ComplianceAnalytical Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementSite Qualification VisitsPatient Recruitment StrategiesKPI Monitoring and ReportingRegulatory Document ManagementContract ManagementOncology Clinical TrialsBiological Sciences DegreeRisk-Based MonitoringInspection Readiness Documentation

Soft Skills

Strong Communication SkillsInfluencing SkillsTeam CollaborationSelf-StarterIndependent Work

Tools & Technologies

CTMSEDCETMFIWRSDashboards/Metrics

Industry Keywords

ICH GuidelinesLocal Regulatory StandardsPharmaceutical IndustryClinical TrialsSite Activation

About the role

Key responsibilities & impact

Work on multiple trials across cross-therapeutic areas with a start-up focus
Collaborate with country operations teams to identify, select, and activate clinical trial sites according to timelines and requirements
Perform Site Qualification Visits to assess site eligibility
Build relationships with site personnel to facilitate onboarding
Ensure compliance with ICH-GCP guidelines, local regulatory standards, and internal SOPs
Coordinate collection of regulatory approvals, contracts, and essential documents for site activation
Act as the main point of contact for sites, study teams, and external stakeholders during start-up
Manage investigator contracts, regulatory documents, and site-specific start-up activities
Provide status updates on project milestones
Monitor, report, and analyze KPIs related to site selection and start-up timelines
Identify and address issues that may delay study initiation or affect trial deliverables
Maintain precise documentation for inspection readiness
Support sites through activation until “Green Light” status
Coordinate completion of pre-study requirements including contracts, budgets, and essential documentation
Assist with audit and inspection preparations

Requirements

What you’ll need

Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
Preferred location is near a major airport
Must have 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials
Have a minimum of 1-3 years' experience monitoring oncology clinical trials
Study Start up experience required
Analytical/risk-based monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet study timelines
Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, dashboards/metrics, IWRS, safety reporting)
Strong communication and influencing skills to effectively manage study sites remotely and face to face
Strong team member and self-starter with the ability to work independently
In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements
Legally authorized to work in the United States
Must not require, now or in the future, sponsorship for employment visa status

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including 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