Senior Clinical Research Associate I

🕒 il y a 9 jours

🇵🇱 Pologne – Télétravail

💵 zł129 750 / an

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 0%

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Pfizer

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1849

💼 Conseil

📣 Marketing

💊 Pharmaceutique

💰 Post-IPO Debt en 2023-05

Consulting • Marketing • Pharmaceuticals

Nous célébrons 175 ans d'innovation scientifique audacieuse - et nous n'avons pas encore terminé. Chaque jour, nous mettons notre passion et nos ressources au service de la mise au point de thérapies innovantes qui changent le visage des soins de santé. Surpassons hier.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

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