Senior Clinical Research Associate

🕒 il y a 19 jours

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UBC

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 2003

🏥 Santé

💼 Conseil

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

UBC est une entreprise dédiée à l'amélioration des résultats pour les patients en reliant les thérapies spécialisées aux patients dans le besoin. Elle offre des solutions modernes et personnalisées axées sur l'accès, la sécurité, et la génération de preuves pour les produits biopharmaceutiques. UBC se spécialise dans le développement de preuves, la gestion des risques, et l'accès des patients, en utilisant des données du monde réel et des technologies innovantes pour optimiser le parcours de soins et assurer l'utilisation efficace des médicaments.

Description

• Monitors clinical trials and observational studies ensuring protocol adherence, managing site activities, and overseeing data collection and integrity. • Ensures sites are conducting the study(ies) and reporting study data as required by applicable regulations and guidelines, and sponsor requirements. • Performs remote and on-site monitoring in accordance with project specific timelines. • Completes travel scheduling in accordance with project specific and UBC travel policy. • Submits expense reports within UBC requirements. • Completes site monitoring reports and letters per UBC and/or sponsor SOPs requiring minimal corrections. • Ensures follow-up of site issues and action items per UBC/sponsor timelines. • Enters site visits, site monitoring reports, follow-up letter sent date and site contacts into Clinical Trial Management System (CTMS). • Monitors within Electronic Data Capture (EDC) data entry, if applicable, and assists sites with electronic Case Report Form (eCRF) resolution. • Reviews Investigator Site File and performs Investigational Product reconciliation. • Maintains regular contact with assigned sites per study requirements. • Completes all SOP review, training assessments and documentation within requested timelines. • Travel up to 50% required in the European region. • Completes Site Management and Monitoring activities in accordance with project specific plans and timelines.

🎯 Exigences

• Bachelor’s degree – Life Science preferred or equivalent years of industry and clinical research experience • Minimum of 24 months’ clinical research experience, specifically in site management and remote monitoring • Preferably at least 6 months’ on-site monitoring experience • Knowledge of medical terminology and regulatory guidelines, including local legislation • Strong attention to detail, excellent organizational skills, and the ability to communicate effectively are essential • Excellent critical thinking and resolution skills • Proven ability to deliver accurate work and adhere to deadlines in a fast-paced environment • Good written and verbal communication skills in English and local language (as applicable) • Experience and familiarity with CTMS, eTMF, EDC, Microsoft Office applications.

🏖️ Avantages

• UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. • We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.