Clinical Research Associate – Senior

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💰 Post-IPO Debt on 2023-05

We’re celebrating 175 years of daring scientific innovation—and we’re not done yet. Every day, we’re channeling our passion and resources into delivering innovative therapies that change the face of healthcare. Let’s outdo yesterday.

📋 Description

• 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

• 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 • 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

• 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