Clinical Research Associate II/Sr. Clinical Research Associate

Parexel

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

Posted 10/22/2026full-timeRemote • Ohio • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial site management, ensuring compliance with ICH/GCP and FDA regulations while maintaining patient safety. Proficient in monitoring, reporting, and resolving site issues to support successful trial execution and investigator relationships.

Highest-signal resume keywords

Clinical Trial MonitoringICH/GCP ComplianceSite ManagementPatient SafetyAdverse Event Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MethodologiesSite ActivationDatabase LockProtocol SupportData Query ResolutionCAPA ActivitiesOnsite MonitoringRemote MonitoringStudy Metrics ReportingInvestigational Product Handling

Soft Skills

CommunicationCoachingProblem-SolvingRelationship ManagementTeam Collaboration

Industry Keywords

Clinical ResearchFDA RegulationsPatient RecruitmentGCP StandardsSite Close-Out ActivitiesDrug SafetyTMF DocumentationQuality Event RemediationEnrollment InitiativesLife Sciences Degree

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 assigned operational aspects from site activation through database lock
Serve as primary point of contact for assigned investigator sites
Facilitate information flow between study team members, vendors and investigator sites
Provide site development, coaching, training and protocol support
Support enrollment and recruitment initiatives
Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and closure
Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
Submit required reports, TMF documentation, site reports, protocol deviations, recruitment and study metrics
Identify and resolve site issues and develop corrective and preventative actions
Resolve data queries and conduct investigator site close-out activities
Oversee investigational product receipt, handling, accounting, storage and destruction
Support database release and, where appropriate, undertake unblinded monitor responsibilities
Maintain product, protocol and therapy-area knowledge and support patient safety and clinical guidance
Drive Quality Event remediation and audit observation CAPA activities when applicable

Requirements

What you’ll need

Minimum 2 years relevant experience in clinical research site monitoring
Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
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

Benefits

Comp & perks

Equal opportunity employer
Qualified applicants receive consideration for employment without regard to legally protected status