Senior Clinical Research Associate – FSP

Parexel

Senior Clinical Research Associate at Parexel managing site activities for clinical trials. Ensuring compliance with protocols, regulatory requirements, and effective communication across teams.

Posted 5/5/2026full-timeRemote • 🇳🇱 NetherlandsSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and sponsor SOPs
Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely
Partner with Clinical Trial Liaison (CTL) and other sponsor functions to support site activation and deliverables
Establish and maintain productive professional relationships with investigator site staff
Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance
Prepare and maintain Oversight Monitoring Plan
Conduct Oversight Monitoring Visits at sites
Review and report on status of study conduct at the investigator site
Ensure site regulatory files are current and timely submission of study documentation
Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues
Maintain ongoing communication with site personnel, study teams, and other stakeholders
Support inspection readiness activities and ensure data integrity and protocol deliverables

Requirements

What you’ll need

Bachelor's degree (or equivalent)
Minimum of 5 years of related experience for Snr CRA
Strong analytical problem-solving skills and critical thinking abilities
Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA)
Effective communication and interpersonal skills to build relationships internally and externally
Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories
Demonstrated ability to deliver clear and concise written reports
Effective prioritisation and time management skills

Benefits

Comp & perks

Health insurance
Paid time off
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

site managementdrug accountabilityprotocol complianceoversight monitoringprotocol deviationsstudy documentationdata integrityclinical drug development processanalytical problem-solvingcritical thinking

Soft Skills

effective communicationinterpersonal skillsrelationship buildingprioritisationtime management

Certifications

Bachelor's degree