Senior Clinical Research Associate II

🔥 15 hours ago

🇵🇱 Poland – Remote

💵 zł217.5k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💼 Consulting

📣 Marketing

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-05

Consulting • Marketing • Pharmaceuticals

Pfizer is a pharmaceutical company that has been at the forefront of scientific innovation for 175 years. The company is dedicated to improving health and well-being at every stage of life by providing access to safe, effective, and affordable medicines and healthcare services. Pfizer focuses on delivering innovative therapies, particularly in the field of cancer treatments, as it continues to progress in transforming the healthcare landscape.

📋 Description

• Manage, monitor and close out assigned clinical trial investigator sites • Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards • Manage operational aspects of trial activities from site initiation through database lock • Serve as primary contact for assigned investigator sites and facilitate communication among study teams, vendors and sites • Develop, coach and train site personnel on protocol compliance and patient safeguarding • Support site enrollment and recruitment initiatives • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and closure • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit required reports, documentation, updates and tracking, including Trial Master File documentation and site reports • Identify and resolve site issues and implement corrective and preventative actions • Resolve data queries and conduct site close-out activities • Oversee investigational product handling and accountability • Support database release and perform unblinded monitoring when required • Maintain product, protocol and therapy-area knowledge and support patient safety • Drive Quality Event remediation and audit observation CAPA activities when applicable • Mentor/train CRAs and serve as a CRA-process subject matter expert • Participate in or lead process-improvement initiatives • Perform Site Care Partner duties for small projects or under guidance on larger projects • Conduct co-monitoring activities

🎯 Requirements

• Experience and capability to perform investigator site management and monitoring for assigned clinical trial sites • Thorough understanding of the product, protocol and therapy area • Ability to ensure compliance with applicable laws, Good Clinical Practices, Pfizer standards, Study Monitoring Plans and SOPs • Ability to manage site initiation, routine monitoring, recruitment, database lock and close-out activities • Ability to monitor and resolve site-level AEs and SAEs • Ability to manage Trial Master File documentation, site reports, protocol deviations, recruitment, clinical supplies, study progress and metrics • Ability to identify and resolve site issues and develop corrective and preventative actions • Ability to oversee investigational product receipt, handling, accounting, storage and destruction • Ability to support patient safety, eligibility and clinical guidance to investigators • Ability to conduct audit support and CAPA development/checks • Ability to mentor/train CRAs and serve as an SME for CRA-related processes • Ability to participate in or lead global, regional or local working groups and process improvement initiatives • Ability to undertake Site Care Partner responsibilities when required • Ability to conduct co-monitoring activities

🏖️ Benefits

• Annual bonus: 15% • Medicover • Multisport • Life insurance • Private pension plan • Flexible workplace culture supporting work-life harmony • Reasonable adjustments for disability inclusion