Senior Clinical Research Associate - FSP

Parexel

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

Posted 10/13/2026full-timeRemote • Ohio • 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 effectively managing investigator site relationships and ensuring patient safety throughout the study lifecycle. Proficient in monitoring, training, and resolving site-related issues to support successful 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

Site ManagementSite MonitoringProtocol TrainingAdverse Event MonitoringDatabase Lock ManagementData Query ResolutionCorrective and Preventive ActionsInvestigational Product HandlingStudy Metrics TrackingEnrollment Support

Soft Skills

CoachingCommunicationProblem-SolvingRelationship ManagementTeam Collaboration

Certifications & Qualifications

Bachelor’s Degree in Life SciencesValid Driver’s LicensePassport

Industry Keywords

Clinical ResearchFDA RegulationsGCP StandardsSite ActivationQuality Event Remediation

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 aspects from site activation through database lock
Serve as primary point of contact for assigned investigator sites
Facilitate information flow among study team members, vendors, and investigator sites
Coach and train site personnel and provide protocol training
Support enrollment and resolve site activation and recruitment issues
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 trial documentation, reports, tracking, and study metrics within required timelines
Identify and resolve investigator 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, where appropriate, undertake unblinded monitor responsibilities
Maintain product, protocol, and therapy-area knowledge and support patient safety and investigator guidance
Drive Quality Event remediation and support audit observation CAPA activities

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

Benefits

Comp & perks

Equal opportunity employer
Travel reimbursement or other travel-related compensation is not explicitly stated