Clinical Research Organisation
  • Clinical Research Organisation
  • Principal Investigator – Adelaide
  • Full Time or Part Time
  • Adelaide, SA

About the role

  • Study Leadership: Provide end-to-end medical and scientific oversight for early-phase (Phase I–II) clinical trials, including first-in-human studies.
  • Safety & Compliance: Ensure all trial operations strictly adhere to study protocols, ICH GCP guidelines, and regulatory standards to safeguard participant welfare.
  • Clinical Care: Conduct participant eligibility assessments, physical exams, medical monitoring, and provide after-hours adverse event management.
  • Trial Planning: Contribute expert medical feedback during study design, feasibility assessments, and protocol development.
  • Stakeholder Collaboration: Partner closely with trial sponsors, CROs, regulatory bodies, and multidisciplinary internal research teams.
  • Medical Credentials: Hold current AHPRA registration with at least 5 years of post-registration clinical experience.
  • Research Experience: Demonstrated history as a Principal Investigator or senior clinical researcher within a clinical trial environment.
  • Certifications: Current ICH GCP and ALS 1 certifications (or a willingness to obtain ALS 1).
    Mentorship & Education: Support staff training, contribute to internal PI education programs, and step in as Sub-Investigator when needed.
  • Location & Commitment: Onsite role based in South Australia, offering full-time employment (with potential consideration for 0.8 FTE).

About the Practice/ Company

  • Industry Position: Australia’s longest-established and one of its largest clinical research organizations, operating for over 30 years with specialisation in early-phase (Phase I–II) and first-in-human studies.
  • Scale & Facilities: A major 78-bed clinical trial unit with over 400 staff members, situated in Adelaide’s BioMed City precinct opposite the Royal Adelaide Hospital.
  • Global Footprint: Serves a database of over 70,000 trial participants and collaborates with global pharmaceutical and biotech clients to meet international regulatory standards (including US FDA and ICH GCP compliance).

Applications and more information