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 patient safety, quality study execution, regulatory/GCP compliance and Pfizer standards • Manage operational clinical-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 • Coach and train site personnel and provide protocol training • Support enrollment, site activation and recruitment initiatives • Conduct onsite and remote/electronic monitoring for initiation, routine monitoring and closure • Monitor adverse events and serious adverse events and follow up with investigators and the Drug Safety Unit • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment and study-progress tracking • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and prepare and conduct site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release and perform unblinded monitoring when required • Maintain product, protocol and therapy-area knowledge and support patient safety and eligibility • Drive Quality Event remediation and support audit conduct and CAPA activities • Mentor/train CRAs and Senior CRAs I • Serve as CRA-process SME and 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/or qualifications sufficient to perform senior clinical research associate site management and monitoring responsibilities • Thorough understanding of the product, protocol and therapy area • Knowledge of applicable prevailing laws, Good Clinical Practices, Pfizer standards, Study Monitoring Plans and SOPs • Ability to manage investigator site relationships and resolve protocol-related issues • Ability to conduct onsite, remote/electronic monitoring and close-out activities • Ability to monitor AEs and SAEs and collaborate with the Drug Safety Unit • Ability to manage investigational product receipt, handling, accounting, storage and destruction • Ability to support database release • Ability to undertake unblinded monitor responsibilities where required • Ability to mentor/train Clinical Research Associates and Senior Clinical Research Associates I • Ability to serve as an SME for CRA-related processes • Ability to participate in or lead working groups and process-improvement initiatives • Ability to perform Site Care Partner duties for small projects or under guidance on larger projects • Ability to conduct co-monitoring activities

🏖️ Benefits

• Annual bonus: 15% • Corporate benefits as per Pfizer Pay Policy, including Medicover, Multisport, life insurance, private pension plan and other • Flexible workplace culture supporting work life harmony • Reasonable adjustments to support disability inclusion