Clinical Research Coordinator

1 dia atrás

São Paulo, São Paulo, Brasil beBeeClinical Tempo inteiro US$65.000 - US$85.000

Job Summary:

Clinical Research Coordinator I

Assists in the management of clinical trials by coordinating site initiation, monitoring, and close-out activities.

Ensures compliance with regulatory requirements, including Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) Guidelines.

Maintains a working knowledge of GCP guidelines, relevant regulations, and company standard operating procedures (SOPs).

  • Coordinates site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory compliance.
  • Develops and maintains tools, procedures, and processes to ensure quality monitoring.
  • Collaborates with cross-functional teams to support audit readiness and prepares for audits and follow-up actions.

Key Responsibilities:

  • Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory compliance.
  • Uses judgment and experience to evaluate overall site performance and provide recommendations regarding site-specific actions.
  • Verifies informed consent process and documentation for each subject/patient.

Requirements:

  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Excellent communication, presentation, and interpersonal skills.

Benefits:

Competitive salary and benefits package.

Opportunities for professional growth and development.

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