Senior Clinical Research Associate II

🕒 vor 10 Tagen

🇵🇱 Polen – Remote

💵 zł217.500 / Jahr

⏰ Vollzeit

🟠 Senior

🧪 Wissenschaftler Klinische Forschung

👻 Geisterscore 0%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Pfizer

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1849

💼 Beratung

📣 Marketing

💊 Pharmazie

💰 Post-IPO Debt im 2023-05

Consulting • Marketing • Pharmaceuticals

Wir feiern 175 Jahre mutige wissenschaftliche Innovation – und wir sind noch nicht am Ende. Jeden Tag lenken wir unsere Leidenschaft und Ressourcen darauf, innovative Therapien zu entwickeln, die das Gesicht des Gesundheitswesens verändern. Lassen Sie uns den gestrigen Tag übertreffen.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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