Senior Clinical Research Associate – FSP

Parexel

. Manage investigator site relationships and assigned clinical trial site activities from site activation through database lock and close-out .

Posted 9/29/2026full-timeRemote • CanadaSeniorWebsite

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 compliance with Good Clinical Practices. Proficient in monitoring clinical trial activities, providing training, and resolving site issues to support successful trial outcomes.

Highest-signal resume keywords

Clinical Trial MonitoringGood Clinical Practices (GCP)ICH GuidelinesSite Relationship ManagementAdverse Event Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MethodologiesSite ActivationDatabase LockProtocol TrainingData Query ResolutionTrial Master File DocumentationQuality Event RemediationCAPA DevelopmentInvestigational Product ManagementRemote Monitoring

Soft Skills

CoachingTrainingCommunicationProblem-SolvingCollaboration

Industry Keywords

Food and Drug Administration (FDA)Clinical ResearchSite MonitoringAdverse EventsStudy Monitoring PlanSite Care PartnerClinical Supply ManagementTherapy-Area KnowledgeRecruitment SupportRegulatory Compliance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage investigator site relationships and assigned clinical trial site activities from site activation through database lock and close-out
Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices (GCP), and Sponsor standards
Serve as primary point of contact for assigned investigator sites and coordinate with the Site Care Partner and study team
Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure
Provide site personnel coaching, training, protocol training, and recruitment support
Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply management, study progress, and metrics
Identify and resolve site issues, develop corrective and preventive actions, and resolve data queries
Ensure oversight of investigational product receipt, handling, accounting, storage, and destruction
Support database release and undertake unblinded monitor responsibilities when appropriate
Maintain product, protocol, and therapy-area knowledge and provide clinical guidance to investigators
Drive Quality Event remediation and support audit observation CAPA development and checks

Requirements

What you’ll need

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Minimum 3 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