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Clinical Trial Assistant (Cell Therapy)

Clinical Trial Assistant (Cell Therapy)

Nexcella, Inc.são paulo, estado de são paulo, br
Há 9 dias
Descrição da vaga

Clinical Trial Assistant (Cell Therapy)

Greater São Paulo Area / Hybrid

Our 3 Core Values

  • Intelligence
  • Integrity
  • Initiative

Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting!

What You'll Do

  • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
  • Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Assist with periodic review of study files for completeness.
  • Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
  • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
  • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
  • May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
  • What We Look For

  • Bachelors degree or equivalent
  • Administrative support experience.
  • Equivalent combination of education, training and experience.
  • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
  • Written and verbal communication skills - must be fluent in both English and local language
  • Effective time management and organizational skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
  • Knowledge of applicable protocol requirements as provided in company training.
  • About Nexcella

    Nexcella Inc., a wholly-owned Immix Biopharma subsidiary, is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.

    Learn more at www.nexcella.com

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    Clinical Trial Assistant • são paulo, estado de são paulo, br

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