Clinical Monitoring Associate

Há 12 horas


São Paulo, São Paulo, Brasil beBeeMonitoring Tempo inteiro R$80.000 - R$120.000
Job Description

Clinical trials rely heavily on the expertise of Clinical Research Associates. As a CRA II, you will be responsible for upholding the integrity and quality of clinical trial data.

  • Key Responsibilities:
  • Develop project plans related to Clinical Monitoring responsibilities.
  • Ensure informed consent procedures and protocol requirements are adhered to.
  • Verify source documents, generate queries, and resolve discrepancies against established data review guidelines.
  • Confirm regulatory documents and eTMF/Sponsor Documents are complete and current.

Requirements:

  • University degree or certification in a related allied health profession from an accredited institution.
  • Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
  • Basic knowledge of monitoring procedures and the clinical trial process.
  • Fluent in English, both written and verbal.

Experience:

  • Minimum 2 years of Clinical Monitoring experience.
  • Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
  • Good planning, organization, and problem-solving abilities.
  • Ability to work efficiently and effectively in a matrix environment.


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