Senior Clinical Research Associate I

🕒 vor 10 Tagen

🇵🇱 Polen – Remote

💵 zł129.750 / 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.

Jetzt Bewerben

Ähnliche Remote-Jobs finden

E-Mail-Benachrichtigung für neue Jobs einrichten

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen

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 investigator sites for clinical trials • Ensure clinical trials follow the Study Monitoring Plan, applicable laws, Good Clinical Practices, and Pfizer standards • Manage operational clinical trial activities from site initiation through database lock • Serve as primary contact for assigned investigator sites and coordinate with the Site Care Partner and study team • Facilitate information flow among study team members, vendors, and investigator sites • Coach and train site personnel on protocols, compliance, patient safety, and operational risks • Support enrollment and resolve site activation and recruitment issues • Conduct onsite and remote/electronic site initiation, routine monitoring, and site closure activities • Monitor site-level AEs and SAEs and collaborate with the Drug Safety Unit • Submit required Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management records, study progress, and metrics • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product handling and accountability at investigator sites • Support database release and undertake unblinded monitor responsibilities when required • Support study clinicians with patient safety, eligibility, and clinical guidance • Drive Quality Event remediation and audit observation CAPA activities when applicable • Mentor/train Clinical Research Associates and participate in process improvement initiatives • Perform pre-activation activities including feasibility, site selection, PTA, activation checklist coordination, ICD finalization, and SIV • Conduct co-monitoring activities as requested

🎯 Anforderungen

• Experience and knowledge sufficient to manage investigator sites and monitor clinical trials • Knowledge of applicable prevailing laws, Good Clinical Practices, Pfizer standards, SOPs, and Study Monitoring Plans • Understanding of the product, protocol, and relevant therapy area • Ability to manage investigator site relationships and resolve protocol-related issues • Ability to monitor adverse events (AEs) and serious adverse events (SAEs) • Ability to manage clinical trial documentation, Trial Master File documentation, reports, tracking, and metrics • Ability to oversee investigational product receipt, handling, accounting, storage, and destruction • Ability to conduct onsite and remote/electronic monitoring • Ability to support patient safety, eligibility, recruitment, database release, and audit/CAPA activities • Ability to mentor/train Clinical Research Associates and serve as an SME for CRA-related processes • Willingness to attend investigator meetings virtually or face-to-face • Willingness to perform feasibility, site selection, site activation, SIV, co-monitoring, and working-group activities as required

🏖️ Vorteile

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