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Clinical Trial Assistant | Assistant aux essais cliniques
2 months ago
Clinical Trial Assistant 35Pharma is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of Montréal, Canada , and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.
Reporting to the Senior Director, Clinical Operations, the Clinical Trial Assistant provides support to the clinical operations team in the execution of all aspects of clinical trial and regulatory operations activities in accordance with International Council for Harmonisation (ICH): Guideline for Good Clinical Practice (GCP), applicable regulations, and 35Pharma Inc. Provide general administrative support to the clinical operations team.
Support the clinical operations project team in the day-to-day management of clinical trial activities such as: prepare and distribute meeting agendas, minutes, and presentations; Set-up, maintain, and ensure completion of project-specific training records.
Manage preparation and distribution of study supplies (i.e., investigator site files (ISF), study material), as necessary.
Distribute information to internal team members and external stakeholders (contract research organizations (CROs), vendors, sites).
Set-up and maintain the clinical operations investigators database.
Collect, track, and file sites essential documents and other required clinical documents for filing in the electronic trial master file (eTMF) under the guidance of the TMF Specialist.
Communicate directly with the CROs, clinical research associates, sites and other internal team members to ensure all documents required for the eTMF are collected and filed in a timely manner.
Contact clinical sites for specific requests (i.e., enrollment updates, missing documentation, etc.)
Assist the Associate Project Managers and Clinical Project Managers in the review of clinical trial agreements and site budgets, create tracking tool to capture costs per procedures per site and site payments, and verify site payment requests against visits and procedures completed in the electronic case report form (eCRF).
May support any clinical and regulatory operations activities as deemed necessary to ensure the clinical program success.
Minimum of bachelor’s degree in health sciences or related degree within life sciences or equivalent experience.
Minimum of 2 years’ experience in a clinical trial assistant or project coordination role in a pharmaceutical or biotechnology company, or a CRO.
Flexible, independent and self-motivated.
An unwavering commitment to the highest quality of work, research ethics and willingness to learn.
Demonstrated proficiency in required software (Word, Excel, PowerPoint) and other clinical systems (i.e., electronic data capture (EDC), eTMF, Quality Management System (QMS)) and computer skills.
Assistant aux essais cliniques
35Pharma est une société biopharmaceutique de stade clinique qui conçoit et développe des thérapies innovantes pour les maladies pulmonaires potentiellement mortelles et les troubles musculo-squelettiques et métaboliques. Nous croyons qu'il est important d'associer une science rigoureuse à notre sens inné de l'urgence afin de générer rapidement des thérapies révolutionnaires pour les patients qui en ont besoin et améliorer leur qualité de vie. Notre équipe hautement qualifiée de développeurs de médicaments et de bâtisseurs d'entreprises a fait ses preuves dans l'avancement de produits biologiques complexes, de la découverte aux essais cliniques. Nos installations de recherche et développement sont situées au cœur de Montréal, au Canada , et comprennent des laboratoires pour la recherche préclinique ainsi que le développement de la fabrication qui renforcent notre mission de servir les patients dans le besoin.
Rapportant au directeur principal, opérations cliniques, l'assistant aux essais cliniques fournira un soutien à l'équipe des opérations cliniques dans l'exécution de tous les aspects des activités d'essais cliniques et d'opérations réglementaires conformément aux ICH/BPC, aux réglementations applicables et aux SOP/politiques de 35Pharma.
Fournir un soutien administratif général à l'équipe des opérations cliniques.
Soutenir l'équipe des opérations cliniques dans la gestion des activités d'essais cliniques : préparer et distribuer les ordres du jour, les procès-verbaux et les présentations des réunions ; Mettre en place, maintenir et assurer l'exhaustivité des dossiers de formation spécifiques au projet.
Gérer la préparation et la distribution des fournitures d'étude (les dossiers d’étude de l’investigateur (ISF), le matériel d'étude), si nécessaire.
Distribuer l'information aux membres de l'équipe interne et aux parties prenantes externes (Organisation de recherche contractuelle ou (CRO), fournisseurs, sites).
Maintenir divers outils et systèmes de suivi et de rapports nécessaires à l'équipe des opérations cliniques.
Mettre en place et maintenir la base de données des investigateurs des opérations cliniques.
Recueillir, suivre, et classer tous les documents essentiels des sites et autres documents cliniques requis dans le système électronique de classement des documents des essais cliniques (« electronic trial master file » ou eTMF), sous la direction du spécialiste TMF.
Communiquer directement avec les CRO, les associés de recherche clinique, les sites et les autres membres de l'équipe interne pour garantir que tous les documents requis pour l'eTMF sont collectés et classés en temps opportun.
Contacter les sites cliniques pour des demandes spécifiques (mises à jour des inscriptions, documentation manquante, etc.)
Aider les gestionnaires de projet associés et les gestionnaires de projet cliniques à réviser les ententes contractuelles d'essais cliniques et les budgets des sites, créer un outil de suivi pour capturer les coûts par procédure par site et les paiements par site, et vérifier les demandes de paiement du site par rapport aux visites et aux procédures effectuées dans les dossiers d’études électroniques («electronic case report form » ou eCRF.
Peut soutenir toute activité des opérations cliniques et réglementaires jugée nécessaire pour assurer le succès du programme clinique.
Au moins un baccalauréat en sciences de la santé ou diplôme connexe en sciences de la vie ou expérience équivalente.
Au moins deux (2) ans d'expérience dans un rôle d'assistant d'essais cliniques ou de coordination de projets dans une entreprise pharmaceutique ou biotechnologique, ou une CRO.
Flexible, indépendant et motivé.
Un engagement inébranlable envers la plus haute qualité de travail, l'éthique de la recherche et la volonté d'apprendre.
Maîtrise démontrée des logiciels requis (Word, Excel, PowerPoint) et d'autres systèmes cliniques (CTMS, EDC, eTMF, QMS) et compétences informatiques.
