Clinical Research Associate

Há 6 dias


Brasil ENGINEERINGUK Tempo inteiro

Job Title: Clinical Research Associate

The In-House CRA performs critical site activation and maintenance tasks, ensuring compliance with sponsor and ICON protocol, SOPs, ICH/GCP guidelines, and applicable regulatory requirements. Key responsibilities include essential document collection and review, clinical status tracking, and site management activities.

Key Responsibilities:

  • Perform routine essential document collection, review, and negotiation to ensure site activation and maintenance.
  • Recruit study sites, ensuring accurate tracking and documentation of clinical data throughout the project lifecycle.
  • Complete submissions and notifications to regulatory authorities, ethics committees, and other bodies.
  • Collaborate with patient management teams to address patient inquiries and issues.
  • Conduct clinical data review, query creation, query resolution, and site management communications as outlined in study plans and SOPs.

Requirements:

  • Bachelor's degree in a clinical, science, or health-related field.
  • Previous experience in clinical research with ethics submissions.
  • Knowledge of ICH and local regulatory authority drug research and development regulations.
  • Advanced English language proficiency, with fluency in the host country language.


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