Clinical Research Associate/Senior

Use Your Power for Purpose

Reporting to the ANZ GSSO Leadership, you will play a critical role in delivering high-quality clinical trials by partnering with investigator sites to ensure patient safety, regulatory compliance, and operational excellence. As a Senior Clinical Research Associate I you will serve as a trusted partner to investigators and study teams, leading site management and monitoring activities from study activation through closeout.

By building strong site relationships, proactively managing risks, resolving protocol-related issues, and supporting site performance, you will help accelerate the delivery of clinical research while maintaining the highest standards of quality and Good Clinical Practice. Working closely with Site Care Partners and cross-functional study teams, your expertise will contribute to successful enrollment, data integrity, database release, and the generation of evidence that advances innovative medicines for patients worldwide.

What You Will Achieve

In this role, you will:

• 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.