Senior Clinical Research Associate

ICON plc

. Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH Good Clinical Practice (GCP) guidelines.

Posted 10/1/2026full-timeRemote • Pennsylvania • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, including site selection, startup activities, and compliance with ICH GCP guidelines. Proficient in managing trial-related issues, ensuring regulatory adherence, and providing leadership in clinical operations projects.

Highest-signal resume keywords

Clinical Monitoring ExperienceOncology Monitoring ExperienceICH GCP Guidelines KnowledgeSite 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 Data VerificationSite File ReconciliationInvestigational Product AccountabilityTrial Management ToolsFeasibility Assessment

Soft Skills

LeadershipCommunicationProblem-SolvingCollaborationAttention to Detail

Industry Keywords

Clinical TrialsRegulatory ComplianceLocal Regulatory AuthorityHealth Care ProfessionalClinical Operations

About the role

Key responsibilities & impact

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH Good Clinical Practice (GCP) guidelines.
Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites.
Performs site startup activities, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget and contract negotiations.
Reviews and verifies accuracy of clinical trial data collected onsite or remotely.
Provides regular site status information to team members and trial management and updates trial management tools.
Completes monitoring activity documents as required by sponsor SOPs.
Works with clinical team members to resolve trial and clinical issues.
Escalates site and trial-related issues until resolved or closed.
Performs essential document site file reconciliation, source document verification, and query resolution.
Assesses investigational product accountability, dispensation, and compliance.
Verifies serious adverse event reporting according to trial specifications and ICH GCP guidelines.
Communicates with investigative sites and updates applicable tracking systems.
Ensures required training is completed and documented.
Functions with little oversight at the senior level and may serve as a subject matter expert.
May be assigned complex studies and/or sites.
Provides leadership to assigned clinical operations projects.
Serves as observation and performance visit leader.
Interacts with other functional areas to resolve site issues and facilitate trial timelines.

Requirements

What you’ll need

An undergraduate degree or it’s 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)
5+ years clinical monitoring experience required (Sr CRA)
Knowledge of ICH and local regulatory authority regulations regarding drug
Read, write and speak fluent English.
Oncology monitoring experience required
Experience doing feasibility/site selection/site start up required.
Budget negotiations experience preferred.
To qualify, applicants must be legally authorized to work in the United States, and should 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