Senior Clinical Research Associate

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Alira Health

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Healthcare Insurance • Consulting

Alira Health est un cabinet de conseil international qui accompagne les entreprises des sciences de la vie dans le développement de solutions innovantes en santé. L’entreprise est spécialisée dans un large éventail de services, notamment la recherche et le développement clinique, la conformité réglementaire et le conseil en management. Alira Health met l’accent sur l’engagement des patients, l’accès au marché et la mise en œuvre de solutions concrètes visant à améliorer les résultats de santé. Elle est engagée en faveur de la durabilité environnementale et participe activement à des actions auprès des communautés ainsi qu’à des initiatives ESG. Alira Health propose également des solutions technologiques, avec pour objectif d’améliorer la recherche en sciences de la vie grâce à l’empathie et à l’excellence scientifique.

501 - 1000 employés

⚕️ Assurance santé

💰 €58 000 000 Venture Round en 2023-01

Description

• Conduct site monitoring responsibilities for clinical trials • Provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality • Review monitoring visit reports, conduct co-monitoring and evaluation visits as needed • Ensure appropriate and timely investigator site visits • Coordinate with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues • Assist in development of study-specific Monitoring Plans and training presentations as required • Manage study budget and act as referent for the sponsor • Prepare consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status • Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests • Comply with and ensure team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs • Conduct audit preparation at study sites as needed

🎯 Exigences

• US: BS/BA from an undergraduate program (life sciences or related discipline preferred) • US: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience with 1 year of management experience • EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and ability to autonomously manage monitoring activities • US: Permanent authorization to work in the U.S. • EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15 Nov 2011. • EU: Graduation in a scientific health field. • US: Strong command of English, both written and verbal • EU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performed

🏖️ Avantages

• Professional development • Global travel • Flexible work programs