Senior Clinical Research Associate – Oncology

Parexel

Senior Clinical Research Associate managing site activities and ensuring protocol compliance in clinical studies. Collaborating with cross-functional teams and maintaining effective site communication.

Posted 5/19/2026full-timeRemote • Florida • 🇺🇸 United StatesSeniorWebsite

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 client SOPs
Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely
Partner with Clinical Trial Liaison (CTL) and other client functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) to support site activation and deliverables
Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct
Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements
Prepare and maintain Oversight Monitoring Plan
Perform review of study metrics, assess CRO Clinical Research Associate (CRA) and Investigator Site performance and identify sites for oversight monitoring visits
Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA
Review site source documentation and verify accurate data capture (ALCOA principles)
Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/action items
Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting
Write and submit accurate monitoring visit reports, oversight monitoring visit reports, and study correspondence in a timely manner
Periodically verify completeness of site documentation (e.g., investigator site file/regulatory binder contents)
Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary
Track, trend, and report issues, escalating them to the appropriate teams when required
Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs
Actively participate in team meetings and process improvement initiatives to enhance study outcomes
Support inspection readiness activities and ensure sites maintain data integrity and protocol deliverables

Requirements

What you’ll need

Bachelor's degree (or equivalent)
Minimum of 5 years of related experience for Senior 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 prioritization and time management skills

Benefits

Comp & perks

Health insurance
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical drug development processICH GCPprotocol compliancedata integritymonitoring planoversight monitoringALCOA principlesdrug accountabilityproblem-solvinganalytical skills

Soft Skills

effective communicationinterpersonal skillscritical thinkingrelationship buildingtime managementprioritizationteam collaborationprocess improvementproblem-solvingreport writing

Certifications

Bachelor's degreeSenior CRA experience