Senior Clinical Research Associate

ICON plc

. Implement and monitor clinical trials to ensure sponsor and investigator obligations are met and comply with local regulatory requirements and ICH GCP guidelines .

Posted 9/18/2026full-timeRemote • Florida • United StatesSenior💰 $110,520 - $138,150 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, including compliance with ICH GCP guidelines and local regulatory requirements. Proficient in site assessment, trial initiation, and effective communication with investigative sites.

Highest-signal resume keywords

Clinical Monitoring ExperienceICH GCP Guidelines KnowledgeOncology Monitoring II/III ExperienceSite Selection and StartupBudget Negotiations Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ImplementationRegulatory Document CollectionInformed Consent ReviewSource Document VerificationAdverse Event ReportingTrial Management ToolsSite File ReconciliationInvestigational Product AccountabilityData VerificationFeasibility Assessment

Soft Skills

LeadershipCommunicationProblem-SolvingCollaborationAttention to Detail

Certifications & Qualifications

Licensed Health Care Professional

Industry Keywords

Clinical TrialsRegulatory ComplianceInvestigative SitesTrial ManagementSponsor Obligations

About the role

Key responsibilities & impact

Implement and monitor clinical trials to ensure sponsor and investigator obligations are met and comply with local regulatory requirements and ICH GCP guidelines
Assess potential investigative sites, initiate trials, instruct site personnel, and close trials at investigative sites
Perform site startup activities, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget and contract negotiations
Review and verify clinical trial data collected onsite or remotely
Provide regular site status information and update trial management tools
Complete monitoring activity documents according to sponsor SOPs
Work with clinical team members to resolve trial and clinical issues
Escalate site and trial issues according to sponsor SOPs
Perform essential document site file reconciliation
Perform source document verification and query resolution
Assess investigational product accountability, dispensation, and compliance
Verify serious adverse event reporting according to trial specifications and ICH GCP guidelines
Communicate with investigative sites and update tracking systems
Ensure required training is completed and documented
Function with little oversight at the senior level
Serve as a subject matter expert for clinical operations monitoring activities
Provide leadership to assigned clinical operations projects
Serve as observation and performance visit leader
Interact with other functional areas to resolve site issues and facilitate trial timelines

Requirements

What you’ll need

An undergraduate degree or its equivalent in clinical, science, or health related field from an accredited institution; a licensed health care professional (i.e. registered nurse) or equivalent work experience required
2-5 years clinical monitoring experience required (CRA 2 for sponsor)
5+ years clinical monitoring experience required (Sr CRA for sponsor)
Knowledge of ICH and local regulatory authority regulations regarding drug
Read, write and speak fluent English
Oncology monitoring II/III experience required
Experience doing feasibility/site selection/site start up required
Budget negotiations experience preferred
Legally authorized to work in the United States and must not require now or in the future sponsorship for employment visa status
Employment with ICON is contingent upon having the legal right to work in the country where the role is based

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