Senior Clinical Research Associate

🕒 il y a 28 jours

🇮🇹 Italie – Télétravail

💵 €45 000 - €60 000 / an

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 1%

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Alira Health

Site WebLinkedInTous les Emplois

501 - 1000 employés

🏥 Santé

🏭 Fabrication

⚕️ Assurance santé

💰 €58 000 000 Venture Round en 2023-01

Healthcare • Manufacturing • Healthcare Insurance

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.

Description

• Conduct site monitoring responsibilities independently for clinical trials • Provide oversight, leadership, and guidance to CRA teams • Ensure protocol compliance, quality, adherence to SOPs, timelines, and budgets • Review monitoring visit reports and conduct co-monitoring and evaluation visits • Coordinate investigator site visits and resolve clinical trial monitoring issues • Assist with monitoring plans, training presentations, ethics documents, and site contract negotiation • Manage study budgets for stand-alone projects and act as sponsor referent • Perform qualification, initiation, interim, and close-out visits remotely and onsite • Prepare accurate and timely monitoring visit reports • Review source documents and verify CRF data integrity • Perform quality control and verification of eTMF/TMF documents • Conduct investigational product accountability and review site regulatory binders • Maintain contact with study sites, assess patient accrual, and respond to sponsor requests • Ensure compliance with ICH GCP guidelines, FDA regulations, and company/sponsor SOPs • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs • Resolve discrepant data queries with CRAs/CTC and data management • Identify site issues and develop problem-solving strategies • Conduct audit preparation at study sites • Participate in internal, client/sponsor, scientific, and other meetings • Assist with CRA training, mentor CRAs, and collaborate on CTMS development and maintenance • Manage conflicting priorities and perform additional assigned duties

🎯 Exigences

• Minimum 4 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry • Ability to autonomously manage monitoring activities • Availability to travel in Italy • Oncology experience required • Strong command of the local language, both written and verbal, in the country where monitoring activities are performed • Adequate English • Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 • Graduation in a scientific health field • Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy • Quality-focused, careful, thorough, and detail-oriented • Strong organizational, analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to multitask, manage priorities, organize time, solve problems, manage stress, and handle ambiguous challenges • Professional, trustworthy, and disciplined • Excellent communication and interpersonal skills with customer service orientation • Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture • Knowledge of clinical research, ICH GCP, local regulations, regulatory and ethical requirements • Ability to establish and maintain positive relationships with sponsors, sites, and project team members

🏖️ Avantages

• Global, collaborative team environment • Opportunities for leadership, mentoring, and professional development through CRA new-hire training and onboarding • Regular, flexible remote and onsite work for clinical trial visits

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