Clinical Trial Assistant (Cell Therapy)

Nexcella, Inc.; São Paulo; Presencial; BRL 30.000 - 60.000; Tempo integral

Resumo da oferta

An innovative biopharmaceutical company is seeking an entry-level administrative professional to support clinical research activities. In this role, you will assist Clinical Research Associates and the Regulatory and Start-Up teams in maintaining essential clinical documents and ensuring compliance with project timelines. Your organizational skills and attention to detail will be crucial as you manage documentation, assist with clinical supplies, and act as a central contact for project communications. This is a fantastic opportunity to start your career in a dynamic and impactful industry, contributing to the advancement of cutting-edge therapies.

Qualificações

• 3 years of administrative support experience required.
• Fluent in English and local language, both written and verbal.

Responsabilidades

• Assist CRAs and RSU team with maintaining clinical documents.
• Track and manage Case Report Forms and clinical data flow.

Conhecimentos

Administrative Support

Time Management

Organizational Skills

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Communication Skills

Knowledge of GCP

Clinical Research Awareness

Formação académica

High School Diploma

Ferramentas

Microsoft Office Suite

Descrição da oferta de emprego

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Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

1. 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.
2. 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.
3. Assist with periodic review of study files for completeness.
4. Assist CRAs and RSU with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
5. Assist with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
6. Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
7. May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications

• High School Diploma or equivalent
• 3 years administrative support experience
• Equivalent combination of education, training, and experience
• Computer skills including working knowledge of Microsoft Word, Excel, and PowerPoint
• Fluent in both English and local language (written and verbal communication skills)
• 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

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

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

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