Clinical Research Associate, U.S. Expert Network

🕒 il y a 3 jours

🗽 New York – Distant

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⏱ Temps Partiel

🟢 Junior

🟡 Intermédiaire

🧪 Chercheur Clinique

🚫👨‍🎓 Aucun diplôme requis

👻 Score fantôme 18%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Alcedis - a HUMA company

Alcedis - a HUMA company

51 - 200 employés

Fondée en 1992

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Alcedis - une entreprise de HUMA est une organisation mondiale de recherche sous contrat (CRO) qui organise et exécute des études cliniques basées sur les données et fait progresser la recherche clinique numérique grâce à des technologies propriétaires. Elle combine des services cliniques de bout en bout - comprenant la gestion de projet, la gestion des données, la surveillance, les affaires réglementaires, la biostatistique, la rédaction médicale et la pharmacovigilance - avec des plateformes logicielles (CRF adaptatifs, applications mobiles, intégrations) et des capacités d'IA/sciences des données pour soutenir le développement biotechnologique et pharmaceutique des essais de phase précoce jusqu'à l'approbation réglementaire et les preuves réelles. Alcedis met l'accent sur des plateformes de style SaaS axées sur la technologie pour améliorer l'efficacité, la qualité des données et les résultats centrés sur le patient.

Description

• Join Alcedis’s U.S.-based expert network of experienced Clinical Research Associates • Support current and future clinical studies within the Clinical Operations team as projects become available • Conduct and support Site Initiation Visits, primarily virtually, in the U.S. and Canada • Perform on-site and remote clinical trial monitoring activities • Collaborate with clinical research professionals and colleagues across U.S. and European time zones • Work on a part-time project basis for the duration of mutually agreed assignments • Discuss study scope, timing, workload, and availability when a suitable project becomes available

🎯 Exigences

• 3+ years of hands-on experience working as a Clinical Research Associate (CRA) / Clinical Monitor • Experience in GCP-regulated interventional clinical trials • Demonstrated experience in oncology clinical trials • Hands-on experience with digital clinical-trial solutions, such as ePRO, eCOA, and eCRF systems • Ability to work independently and proactively with a high degree of ownership • Experience with on-site monitoring and remote monitoring activities • Willingness to conduct and support Site Initiation Visits, primarily virtually, in the U.S. and Canada • Strong communication and organizational skills • Excellent written and spoken English • Based in the United States • Preferred: experience in Neurology and/or Alzheimer’s disease • Preferred: experience working in international or cross-border clinical research teams • Preferred: ability and flexibility to collaborate across U.S. and European time zones, including regular interaction with colleagues based in Germany • Preferred: experience with U.S. and Canadian clinical trial requirements • Preferred: familiarity with FDA regulations, HIPAA, and 21 CFR Part 11

🏖️ Avantages

• Part-time W-2 employment on a project basis for the duration of a project • Flexible participation based on project needs and mutual availability • Ability to continue working with other clients outside the agreed assignment, subject to confidentiality and conflict-of-interest requirements • Compensation for required project-specific qualification or pre-engagement activities involving actual work beyond the application and selection process • Access to selected clinical trial projects through the expert network

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