Medical Monitor

General role description

Medical Monitors are medically trained professionals who help ensure the safety of participants during clinical trials. They review safety data, assess medical issues that arise during a study, and support the trial team to make sure the research is conducted ethically and according to the study plan.

Medical Monitors may work in organisations that run clinical trials for other companies (Contract Research Organisations, or CROs), or within pharmaceutical, biotechnology, or medical device companies managing trials for their own products.

Key responsibilities

  • Monitor participant safety throughout a clinical trial by reviewing reports of adverse events and other medical data
  • Respond to questions from clinical trial sites about the medical aspects of the study or participants
  • Review and help prepare trial documents such as study plans, safety reports, and consent forms
  • Assess whether trial participants meet eligibility criteria and provide input on safety concerns or protocol deviations
  • Participate in meetings or safety committees that assess risks during a clinical trial
  • Work closely with clinical operations, regulatory, and data teams to ensure the study runs smoothly
  • Stay informed about relevant clinical research, treatment guidelines, and emerging safety data
  • Ensure all activities follow legal, ethical, and scientific standards such as Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.

Workplace settings

  • Contract Research Organisations (CROs)
  • Pharmaceutical, biotechnology and medical device companies

Required qualifications

  • A medical degree and registration (or eligibility for registration) with the Medical Board of Australia
  • Experience in clinical trials, pharmacovigilance, or drug/device development is preferred

Other notable requirements

Medical Monitors often need:

  • Strong understanding of clinical trial procedures and safety requirements
  • Good judgment and attention to detail when reviewing patient safety data
  • Confidence working with doctors, trial site staff, and internal teams
    Ability to explain complex medical issues clearly and make decisions quickly
  • Familiarity with ethical guidelines, safety reporting, and regulatory standards such as GCP (Good Clinical Practice) and ICH (International Council for Harmonisation).

Common Next Roles

Senior Medical Monitor

Clinical Development Manager

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