Principal Investigator (Clinical Trials)

Alternate Titles:

Clinical Research Physician, Lead Investigator

General role description

Principal Investigators (PIs) are senior clinicians responsible for leading clinical trials at a specific hospital, clinic, or research site. They make sure the trial is carried out safely, ethically, and according to the approved trial protocol.

PIs oversee the study team, which might include other doctors, research nurses, and coordinators, and ensure that participants receive the right care.

Although PIs usually work for a health service, they often run trials in partnership with pharmaceutical companies, medical device companies, or contract research organisations (CROs) who sponsor the research.

Key responsibilities

  • Lead the clinical trial at the site and make sure it follows all ethical and regulatory approvals
  • Supervise the trial team, including research nurses and other investigators
  • Support participants throughout the trial and provide care for any trial-related side effects
  • Make sure consent is obtained properly and kept up to date
  • Report any serious side effects, changes to the study, or safety issues
  • Work closely with sponsors, CROs, and the local research office
  • Keep clear and accurate records of all study activities
  • Support good research practices and mentor others involved in the trial.

Workplace settings

  • Healthcare settings
  • Contract research organisations (CROs)

Required qualifications

  • A medical degree and current registration as a doctor in Australia.

Other notable requirements

Principal investigators often require:

  • Clinical experience in the relevant area of medicine
  • Training in Good Clinical Practice (GCP) is usually expected
  • Experience running or supporting clinical trials
  • Strong leadership and communication skills
  • Good understanding of ethics and safety in research
  • Confidence making clinical decisions during a study
  • Ability to manage documentation and work with trial partners.

Common Next Roles

Coordinating Principal Investigator (leads multi-site trials)