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, quality study execution and compliance with laws, Good Clinical Practices and Pfizer standards • Manage investigator site relationships and support enrollment, database release and site quality • Serve as primary contact for assigned investigator sites during study conduct • Coordinate information flow among study team members, vendors and investigator sites • Partner with the Site Care Partner on site development, coaching, training and recruitment initiatives • Attend investigator meetings when required, virtually or face-to-face • Conduct remote assessment of e-diary data • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and closure • Monitor site-level 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 • Maintain product, protocol and therapy-area knowledge and interact with healthcare professionals • Support the study clinician in patient safety and clinical guidance • Drive Quality Event submission/remediation and support audits and CAPA activities

🎯 Requirements

• Understanding of the product, protocol and therapy area • Knowledge of applicable prevailing laws, Good Clinical Practices and Pfizer standards • Ability to manage and monitor investigator sites from site initiation through database lock and close-out • Ability to resolve protocol-related issues, data queries and investigator site issues • Ability to monitor adverse events (AEs) and serious adverse events (SAEs) • Ability to manage Trial Master File documentation, site reports, protocol deviations, recruitment tracking, clinical supply management and study metrics • Ability to oversee investigational product receipt, handling, accounting, storage and destruction • Ability to conduct remote/electronic and onsite monitoring • Ability to support patient safety, eligibility and clinical guidance • Ability to drive Quality Event remediation and Audit Observation CAPA development • No explicit educational credential or minimum experience requirement stated

🏖️ Benefits

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