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Clinical Trial Assistant – F/H

Type de contrat : CDI
Région : Auvergne-Rhône-Alpes
Niveau de formation : Bac +2
Rémunération : non précisé
Famille de métier : Recherche clinique

Présentation société

Carthera® est une société de medtech en phase d’évaluation clinique qui développe des dispositifs médicaux innovants basés sur l’utilisation des ultrasons pour traiter un large éventail de pathologies cérébrales graves

Carthera, a French clinical-stage medtech company focused on developing innovative ultrasound-based medical devices to treat a wide range of severe brain disorders, is looking for a Clinical Trial Assistant.

Carthera has developed the SonoCloud®, a revolutionary medical device that emits ultrasound to temporarily increase the permeability of blood vessels in the brain. SonoCloud® is an intracranial implant that opens the blood-brain barrier (BBB) prior to injection of therapeutic agents such as chemotherapy or immunotherapy. A few minutes of low-intensity pulsed ultrasound (LIPU) is sufficient to open the BBB for several hours, thus increasing the concentration of therapeutic molecules in the brain, and potentially their effectiveness.

Oncology indications (glioblastoma, brain metastases) are the company's main target, and research is also underway for other conditions, including neurodegenerative diseases, in particular Alzheimer's disease.

Carthera is looking for an assistant to support the clinical department team in the conduct of ongoing and future clinical investigations.

 

Mission of the position

Assist Project Manager and Clinical team in the organization and management of clinical programs in compliance with procedures and regulatory requirements.

 

Main activities and tasks of the position

  • Create and maintain Trial Master Files in collaboration with the clinical team
  • Participate to the preparation and manage distribution of mailings, documents, and other study materials
  • Participate in the preparation and submission of regulatory packages
  • Assist in the management of contracts with investigators and external vendors, and in the follow-up of payments
  • Collect study-specific data and maintain clinical study records
  • Coordinate ordering, purchasing and logistics of clinical trial materials including investigational products (management of stocks and supplies)
  • Participate in setting up and maintaining procedures of the quality system management
  • Organize internal and external meetings including minutes
  • Assist the clinical team with communication and issue resolution with sites and vendors

 

Hierarchical position

  • Report to the Head of Clinical Affairs
  • Work closely with the Clinical Project Manager and Clinical Trial Managers
  • Interact with other members of the team including people from the Quality and Regulatory department, and Research and Development department

 

Carthera offers

  • the opportunity to actively participate in the development of a disruptive technology in a dynamic company and to be part of a small, friendly, and supportive team marked by a "start-up" spirit
  • ongoing sharing of Information and mentorship to further develop your skills
  • the option to work part-time from home

Descriptif du profil

  • Relevant experience in the field of clinical research
  • Fluent verbal and written English
  • Strong computer knowledge (MS Word, Excel, PowerPoint and Outlook)
  • Ability to multi-task
  • Dynamic, organized, autonomous and rigorous, with good communication skills and keen to work in a flexible and demanding environment

Postuler

Charlotte Schmitt
charlotte.schmitt@carthera.eu



Dernière mise à jour : 23/05/2022