Senior Clinical Research Associate - Central or Western US

Parexel

. Manage site management, site monitoring and close-out of assigned clinical trial investigator sites .

Posted 10/9/2026full-timeRemote • Illinois • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of clinical trial methodologies, ICH/GCP, and FDA regulations while managing site monitoring and ensuring patient safety. Proficient in coordinating site activities, providing training, and resolving site issues throughout the clinical trial process.

Highest-signal resume keywords

Clinical Trial MethodologiesICH/GCP ComplianceSite MonitoringAdverse Event MonitoringBachelor’s Degree in Life Sciences

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site ManagementSite MonitoringProtocol SupportData Query ResolutionInvestigational Product HandlingDatabase Lock ManagementTMF DocumentationCorrective and Preventive ActionsPatient Safety ManagementClinical Research Experience

Soft Skills

Relationship ManagementCoachingTrainingProblem SolvingCommunication

Certifications & Qualifications

Valid Driver’s LicensePassport

Industry Keywords

Clinical ResearchFDA RegulationsGCP StandardsSite ActivationPatient EligibilityQuality Study ExecutionSite Care PartnersDrug Safety UnitAudit CAPA ActivitiesRemote Monitoring

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage site management, site monitoring and close-out of assigned clinical trial investigator sites
Ensure patient safety and quality study execution in accordance with applicable laws, GCP and sponsor standards
Manage investigator site relationships and operational trial activities from site activation through database lock
Serve as primary point of contact for assigned investigator sites
Coordinate with Site Care Partners, study teams, vendors and investigator sites
Provide site development, coaching, training and protocol support
Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and site closure
Monitor adverse events and serious adverse events and collaborate with Drug Safety Unit
Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment and study progress updates
Identify and resolve site issues and develop corrective and preventive actions
Resolve data queries and conduct investigator site close-out activities
Oversee investigational product receipt, handling, accounting, storage and destruction
Support database release and potentially perform unblinded monitoring
Maintain product, protocol and therapy-area knowledge
Support patient safety, eligibility and clinical guidance
Drive quality-event remediation and audit CAPA activities

Requirements

What you’ll need

Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
Minimum 2 years relevant experience in clinical research site monitoring
Fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Benefits

Comp & perks

Equal opportunity employer statement
Opportunity to contribute to therapies benefiting patients and improving global health