Clinical Research Associate/Senior Clinical Research Associate

Parexel

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

Posted 11/4/2026full-timeRemote • 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 with study teams and resolving protocol-related issues to support successful clinical trial execution.

Highest-signal resume keywords

Clinical Trial MethodologiesICH/GCP ComplianceSite MonitoringPatient Safety ManagementFluency in English and Native Language

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchSite ManagementProtocol ComplianceAdverse Event MonitoringDatabase Lock ManagementTMF DocumentationPatient RecruitmentData Query ResolutionInvestigational Product HandlingCorrective and Preventive Actions

Soft Skills

Relationship ManagementCoaching and TrainingProblem SolvingCommunication

Certifications & Qualifications

Bachelor’s Degree in Life SciencesValid Driver’s LicensePassport

Industry Keywords

FDA RegulationsClinical Trial ExecutionSite ActivationQuality Event RemediationAudit CAPA Activities

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 resolve protocol-related issues
Manage clinical trial activities from site activation through database lock
Serve as primary contact for assigned investigator sites
Coordinate with Site Care Partners, study teams, vendors and investigator sites
Coach and train site personnel on protocols and compliance
Support site activation, patient recruitment and enrollment
Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and site closure
Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment and study progress reports
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, storage, accounting and destruction
Support database release and perform unblinded monitoring where appropriate
Maintain product, protocol and therapy-area knowledge
Support patient safety, eligibility and clinical guidance
Drive Quality Event remediation and audit CAPA activities when applicable

Requirements

What you’ll need

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Minimum 2 years relevant experience in clinical research site monitoring
Must be 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