Clinical Trials Professional

Há 10 horas

São Paulo, São Paulo, Brasil beBeeMonitoring Tempo inteiro R$70.000 - R$90.000
Site Monitoring Specialist

As a Site Monitoring Specialist, you will play a crucial role in ensuring the success of our clinical trials. Your primary responsibility will be to manage and conduct site visits according to established guidelines and project plans.

Key Responsibilities:
  • Verify study training records and ensure that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
  • Conduct site monitoring responsibilities for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
  • Prepare and implement project plans related to Clinical Monitoring responsibilities.
  • Safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines.
  • Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.

You will work closely with our study team to align monitoring to critical study timelines, ensuring study deliverables are met. Additionally, you will prepare and implement study-specific monitoring plans and site initiation slides as assigned.

Requirements:
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
  • A minimum of 2 years of Clinical Monitoring experience, preferably in a similar field.
  • Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
  • Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.

This is an exciting opportunity to work on clinical research projects and develop your skills in site monitoring. As a Site Monitoring Specialist, you will have the opportunity to contribute to the success of our organization and advance your career in the field of clinical research.

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