Vaga de parceiro

Clinical Research Associate II (Cell Therapy) - São Paulo / SP

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Detalhes da Vaga

  • Escolaridade Não Informado
  • Segmento Não Informado
  • Salário Não Informado
  • Área de AtuaçãoDiversos / Outros

O que você irá fazer

  • The CRA will perform key job functions in accordance with ICH Good Clinical Practice (ICH GCP), FDA regulations, Nexcella SOPs and work practices while supporting the organizational mission to advance the development of promising oncology therapies and technologies to benefit patients.
  • CRAs are expected to work in a hands-on, highly visible and autonomous role.
  • CRAs must have the ability to be flexible and represent Nexcella in a positive and professional manner while collaborating across all levels with the clinical teams and Sponsors/vendors.
  • Location:This is a remote-based position.
  • Occasional Site travel (<50% and subject to business needs).
  • Nexcella cannot guarantee the location of sites and CRAs should expect travel anywhere in the continental United States.
  • Responsibilities : Perform site selection, initiation, monitoring, and close-out visits of investigational sites for the Nexcella portfolio of clinical trials.
  • Manage the progress of assigned sites by tracking patient recruitment and enrollment, CRF completion and submission, source data verification, data collection, and data query generation and resolution.
  • Conduct monitoring activities, including, but not limited to the following: o Ensuring PI oversight of all trial activities o Source data review and verification with EDC fields o Essential documentation review and reconciliation o Investigational Product (IP) management and accountability o Lab/kit supply management Develop collaborative relationships with investigative sites and personnel.
  • Maintain communication with sites through frequent contact to ensure site compliance, adequate enrollment, and understanding of study requirements.
  • Write and submit complete and accurate visit letters and reports of investigational site findings and update applicable CTMS.
  • Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
  • Participate in audit preparations and follow-up, as needed.
  • Review and address protocol deviations, data quality issues, and identify process improvements for assigned sites.
  • Be a collaborative member of the study team: provide insight, updates, and strategies to improve processes.
  • Ability to think critically while prioritizing tasks in an efficient manner to meet study deliverables.
  • Contribute to CRF development and perform User Access Testing, as requested.
  • Assist with other duties as assigned.
  • Qualifications: Bachelors degree in life science/biomedical/medical science with a proficient knowledge of the clinical/scientific terminology and methods common to the oncology therapeutic setting.
  • 2+ years clinical research experience is required.
  • 2+ years experience at a CRO or Sponsor required.
  • Independent field monitoring experience of oncology clinical trials is required.
  • Early phase oncology experience is preferred.
  • Proficient knowledge and practical utilization of ICH- GCP and applicable regulatory requirements.
  • Strong communication (written and verbal) and interpersonal skills.
  • Demonstrate effective presentation skills by clearly explaining complex concepts to a broad range of audiences.
  • Ability to independently prioritize tasks with excellent time management skills.
  • Highly proficient in computer applications including Microsoft suite of applications, EDC and CTMS applications.
  • Fluent in English (written and verbal) Ability and willingness to travel as required (<50%), to include possession of the appropriate qualifications per independent sites regulations (to include but not limited to vaccinations).
  • 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.

Informações Adicionais

  • Quantidade de Vagas 1
  • Jornada Não Informado
 

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