Senior Clinical Research Associate

🕒 il y a 10 jours

🇵🇱 Pologne – Télétravail

💵 zł129 750 / 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 proper clinical trial conduct according to the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards • Manage operational implementation of clinical trial activities from site initiation through database lock • Serve as primary contact for assigned investigator sites during study conduct • Facilitate information flow among study team members, vendors and investigator sites • Perform investigator site development, coaching and training of site personnel • Attend investigator meetings when required, virtually or face-to-face • Support enrollment and resolve site activation and recruitment issues • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and closure • Monitor site-level AEs and SAEs and follow up with investigators to resolve reporting issues • Submit required reports, documentation, updates and tracking within required timeframes • Identify and resolve investigator site issues and develop corrective and preventive actions • Resolve data queries and prepare and conduct site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release as needed • Undertake unblinded monitor responsibilities where required • Maintain product, protocol and therapy-area knowledge and interact with healthcare professionals • Support the study clinician on patient safety, eligibility and clinical guidance • Drive Quality Event remediation and support audits and CAPA activities when applicable • Mentor and train Clinical Research Associates • Serve as SME for CRA-related processes • Participate in regional or local working groups and 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 capability to perform site management, site monitoring and close-out of assigned clinical trial investigator sites • Knowledge of applicable prevailing laws, Good Clinical Practices and Pfizer standards • Ability to manage investigator site relationships and clinical trial delivery • Ability to resolve protocol-related issues • Ability to conduct onsite and remote/electronic monitoring • Ability to monitor AEs and SAEs and collaborate with the Drug Safety Unit • Ability to manage Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supplies, study progress and metrics • Thorough understanding of the product, protocol and therapy area • Ability to support patient safety, eligibility and clinical guidance to investigators • Ability to drive Quality Event remediation and Audit Observation CAPA development and checks when applicable • Ability to mentor/train Clinical Research Associates • Ability to serve as an SME for CRA-related processes • Ability to perform feasibility, site selection, PTA, site activation checklist coordination, ICD finalization and SIV activities under guidance of a Site Care Partner • Ability to conduct co-monitoring activities as requested

🏖️ Avantages

• Annual bonus: 15% • Medicover • Multisport • Life insurance • Private pension plan • Other corporate benefits as per Pfizer Pay Policy • Flexible workplace culture supporting work-life harmony • Reasonable adjustments for disability inclusion