Clinical Research Associate

🔥 16 hours ago

🇵🇱 Poland – Remote

💵 zł100.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 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 and quality study execution in accordance with laws, Good Clinical Practices and Pfizer standards • Manage investigator site relationships and support enrollment, database release, site quality, compliance and staff engagement • Resolve protocol-related issues and collaborate with the Site Care Partner and study team • Serve as primary contact for assigned investigator sites during study conduct • Facilitate information flow between study team members, vendors and investigator sites • Develop, coach and train site personnel on protocols and compliance • Attend investigator meetings when required • Support site activation and recruitment initiatives • Conduct remote assessment of e-diary data • Conduct onsite, remote and electronic monitoring for site initiation, routine monitoring and site closure • Monitor AEs and SAEs and collaborate with the Drug Safety Unit • Submit required reports, documentation, updates and tracking within required timeframes • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release and undertake unblinded monitor responsibilities where appropriate • Support clinical risk monitoring, audit conduct, quality event remediation and Audit Observation CAPA activities

🎯 Requirements

• Site management and monitoring experience for assigned clinical trial investigator sites • Knowledge of applicable prevailing laws, Good Clinical Practices, Pfizer standards, Study Monitoring Plans and SOPs • Ability to manage investigator site relationships and clinical trial activities from site initiation through database lock • Ability to resolve protocol-related issues, data queries, site issues and corrective/preventive actions • Ability to monitor adverse events (AEs) and serious adverse events (SAEs) • Ability to manage Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supplies, study progress and metrics • Understanding of the product, protocol and therapy area sufficient for discussions with investigators and site teams • Ability to support patient safety, eligibility and clinical guidance • Ability to oversee investigational product receipt, handling, accounting, storage and destruction • Ability to conduct remote, electronic and onsite monitoring • Ability to attend investigator meetings when required, virtually or face-to-face • Ability to work remotely in Poland

🏖️ Benefits

• Annual bonus: 10% • Medicover • Multisport • Life insurance • Private pension plan • Flexible workplace culture supporting work-life harmony • Reasonable adjustments for disability inclusion