General description of the Functional Area:
The Medical / Clinical Operations functional area is responsible for ensuring the safe, ethical, and compliant delivery of clinical research through robust medical governance, with a strong focus on participant safety, eligibility decision‑making, and the management of protocol deviations with medical impact. The function supports early‑phase and first‑in‑human (FIH) clinical trials by embedding medical risk management and regulatory compliance that enable high‑quality study delivery and positive participant experience across all Australian clinics.
The Objectives for this Position are to:
- Provide high‑quality medical services to participants enrolled in clinical trials.
- Ensure participant safety, informed consent integrity, and accurate eligibility assessment.
- Support Medical Pod Managers with assigned operational portfolios where requested and within scope of training.
- Contribute to continuous improvement of medical operations.
The key responsibilities of this position are:
1. Provision of Medical Services & Participant Care
- Provide high‑quality medical services to participants in accordance with clinical trial protocols, ICH‑GCP, and Nucleus Network SOPs.
- Comply with the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as annotated by the TGA, and all relevant ethical and legal requirements, including the Declaration of Helsinki.
- Comply with Alfred Health, Nucleus Network, and other relevant health agency policies and SOPs where applicable.
2. Investigator Responsibilities
- Act as Sub‑Investigator on delegated Nucleus Network clinical studies.
- When delegated by the Medical Director, act as Principal Investigator for healthy volunteer studies.
3. Informed Consent & Eligibility Assessment
- Provide and document informed consent to potentially eligible participants, ensuring no study‑related procedures occur prior to valid PICF completion.
- Ensure participants are consented to the correct PICF and study component (e.g. SAD/MAD).
- Verify participant identity during screening.
- Conduct and document thorough medical histories and physical examinations during screening.
- Review and sign off relevant documentation (e.g. laboratory results, diagnostic tests, inclusion/exclusion criteria) to determine participant eligibility.
4. Participant Safety & Medical Management
- Review and update the Subject Management System (SMS) with new or updated medical information.
- Liaise with participants’ GPs or specialists where required to assess eligibility or manage abnormal findings.
- Refer participants for appropriate medical follow‑up where findings fall outside the scope of the clinical trial.
- Prescribe investigational products and concomitant medications within scope of practice and delegation.
- Medically manage and supervise research on healthy volunteers and patients participating in clinical trials.
5. Trial Conduct, Quality Support & Adverse Event Management
- Perform protocol‑required medical activities, including physical examinations and assessment of injection‑site reactions.
- Attend outpatient reviews for participants as required.
- Counsel participants undergoing HIV or hepatitis testing as part of screening.
- Review adverse event reports for accuracy, severity, seriousness, and relationship to study drug.
- Maintain understanding of potential adverse reactions for assigned studies.
- Participate in administration of investigational products and other on‑study medical activities when required.
- Support Medical Pod Managers with quality event investigations, root cause analysis, and documentation where requested and within scope of training.
6. Education, Process Improvement & Portfolio Support
- Participate in medical education activities, including peer teaching, supervision, and knowledge sharing.
- Contribute to process improvement initiatives and projects as delegated.
- Support assigned operational portfolios under the guidance of the Medical Pod Manager where appropriate.
Pay: $124,000.00 – $129,500.00 per year
Work Location: In person
