Clinical Research Associate II

ICON plc

. Serve as the primary point of contact between investigational sites and the sponsor .

Posted 10/2/2026full-timeRemote • Texas • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site monitoring, compliance with ICH-GCP and local regulations, and proficiency in clinical systems such as CTMS and eTMF. Capable of effectively managing site interactions, ensuring patient safety, and supporting recruitment efforts.

Highest-signal resume keywords

Site Monitoring ExperienceICH-GCP ComplianceCTMS ProficiencyETMF ManagementProblem-Solving Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site SelectionRoutine MonitoringClose-Out VisitsData EntryDrug Accountability

Soft Skills

Clear CommunicationCollaborative Team Player

Tools & Technologies

CTMSETMF

Industry Keywords

Pharmaceutical IndustryCRO IndustryTherapeutic AreasPatient SafetyAE/SAE/PQC Reporting

About the role

Key responsibilities & impact

Serve as the primary point of contact between investigational sites and the sponsor
Conduct site selection, initiation, routine monitoring, and close-out visits
Ensure site compliance with ICH-GCP, SOPs, and regulations
Maintain documentation in CTMS and eTMF systems
Support and track site staff training and compliance records
Monitor patient safety and ensure timely AE/SAE/PQC reporting
Support subject recruitment and retention efforts
Oversee drug accountability and proper storage, return, or destruction
Resolve data queries and drive timely, high-quality data entry
Document site progress and escalate risks or issues
Assist with site budgets and payments as applicable
Collaborate with CTAs, LTMs, and CTMs

Requirements

What you’ll need

A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
Eligible to work in United States without visa sponsorship
2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
Experience monitoring across multiple therapeutic areas
Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
Willing and able to travel up to 60% - 75% for on-site monitoring visits across southeast region
Clear communicator, problem-solver, and collaborative team player

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