Clinical Research Associate – Senior

Pfizer

Senior Clinical Research Associate leading site management and monitoring for clinical research trials. Ensuring patient safety and operational excellence while collaborating with various stakeholders.

Posted 7/15/2026full-timeRemote • 🇦🇺 AustraliaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including site monitoring, compliance with GCP and regulatory requirements, and effective patient recruitment strategies. Possesses strong operational knowledge of study protocols and therapeutic areas, particularly in Oncology.

Highest-signal resume keywords

Clinical Trial ManagementSite Monitoring ExperienceKnowledge of ICH/GCPOncology Therapeutic ExperiencePatient Safety Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MethodologiesRegulatory ComplianceRisk-Based MonitoringData Integrity ManagementProtocol GuidanceAdverse Event ReportingCAPA ImplementationStudy Documentation MaintenancePatient Recruitment StrategiesOperational Excellence

Soft Skills

Strong CommunicationPartnership BuildingMentoringProblem SolvingCollaboration

Certifications & Qualifications

Bachelor’s Degree in Life SciencesValid Driver’s LicensePassport

Industry Keywords

Good Clinical Practice (GCP)FDA RegulationsOncologyVaccinesInternal MedicineInfectious DiseasesGlobal Clinical TrialsClinical ResearchSite OperationsStudy Closeout

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead site management and monitoring activities across assigned clinical trial sites, ensuring studies are conducted in accordance with protocol, Good Clinical Practice (GCP), regulatory requirements, and Pfizer standards.
Serve as the primary point of contact for investigator sites, building strong partnerships to support high-quality study delivery and successful trial outcomes.
Manage site operations from study start-up through closeout, ensuring key milestones, timelines, and quality objectives are achieved.
Conduct onsite, remote, and risk-based monitoring activities, including site initiation, routine monitoring visits, and closeout visits.
Partner with Site Care Partners and cross-functional study teams to identify and mitigate risks, resolve site issues, and drive operational excellence.
Support patient recruitment and enrollment efforts by collaborating with investigators and study teams to address site-level challenges and implement recruitment strategies.
Provide protocol guidance, training, and coaching to investigator site personnel to ensure compliance, quality execution, and patient safety.
Develop and maintain strong scientific and operational knowledge of study protocols, investigational products, and therapeutic areas to effectively support investigators and site teams.
Drive the identification, escalation, and resolution of site quality, compliance, and data integrity issues, including implementation of corrective and preventive actions (CAPAs).
Monitor and support patient safety activities, including adverse event and serious adverse event reporting and follow-up.
Ensure timely completion and maintenance of essential study documentation, trial records, and regulatory compliance requirements throughout the study lifecycle.
Contribute to continuous improvement initiatives by mentoring junior CRAs, sharing best practices, and participating in local and regional process improvement projects.

Requirements

What you’ll need

Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Proficiency in English, both written and verbal
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required

Benefits

Comp & perks

Paid parental leave
Access to Health & Wellness apps
Career Growth Experiences program
Recognition & rewards program
Paid volunteer days
Life Insurance Benefits
Pfizer Learning Academy access to top content providers
Access to flu vaccines & skin checks
Options to purchase additional leave
Salary packaging & novated lease options