Senior Clinical Research Associate II

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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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

• Responsible for investigator site management and monitoring for assigned sites • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met • Work in partnership with and/or escalate to the SCP to ensure quality of site delivery • Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites • Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities • Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed to bring SAE reports required information to resolution • Submit all required reports, documentation, updates and tracking within required timeframes

🎯 Requirements

• Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent • Minimum 3 years relevant experience in clinical research site monitoring (some experience in Oncology) • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Must be fluent in English and in the native language(s) of the country they will work in.

🏖️ Benefits

• Health insurance • Flexible work hours • Paid time off • Professional development opportunities