Senior Clinical Research Associate II

🕒 il y a 9 jours

🇵🇱 Pologne – Télétravail

💵 zł217 500 / an

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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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 clinical trial investigator sites • Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards • Manage operational aspects of 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 • Develop, coach and train site personnel on protocol compliance and patient safeguarding • Support site enrollment and recruitment initiatives • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and closure • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit required reports, documentation, updates and tracking, including Trial Master File documentation and site reports • Identify and resolve site issues and implement corrective and preventative actions • Resolve data queries and conduct site close-out activities • Oversee investigational product handling and accountability • Support database release and perform unblinded monitoring when required • Maintain product, protocol and therapy-area knowledge and support patient safety • Drive Quality Event remediation and audit observation CAPA activities when applicable • Mentor/train CRAs and serve as a CRA-process subject matter expert • 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

🎯 Exigences

• Experience and capability to perform investigator site management and monitoring for assigned clinical trial sites • Thorough understanding of the product, protocol and therapy area • Ability to ensure compliance with applicable laws, Good Clinical Practices, Pfizer standards, Study Monitoring Plans and SOPs • Ability to manage site initiation, routine monitoring, recruitment, database lock and close-out activities • Ability to monitor and resolve site-level AEs and SAEs • Ability to manage Trial Master File documentation, site reports, protocol deviations, recruitment, clinical supplies, study progress and metrics • Ability to identify and resolve site issues and develop corrective and preventative actions • Ability to oversee investigational product receipt, handling, accounting, storage and destruction • Ability to support patient safety, eligibility and clinical guidance to investigators • Ability to conduct audit support and CAPA development/checks • Ability to mentor/train CRAs and serve as an SME for CRA-related processes • Ability to participate in or lead global, regional or local working groups and process improvement initiatives • Ability to undertake Site Care Partner responsibilities when required • Ability to conduct co-monitoring activities

🏖️ Avantages

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