Clinical Trials Sub-Investigator (East Melbourne)

Clinical Trials Sub-Investigator (East Melbourne)

11 Nov
|
Sinclair Dermatology
|
East Melbourne

11 Nov

Sinclair Dermatology

East Melbourne

About us:

Sinclair Dermatology is one of Australia’s largest and most innovative dermatology practices seeing over 70,000 patients per year. Featuring a specialist clinic with more than 16 dermatologists, 6 fellows and a plastic surgeon, spread over three locations. We also house Australia’s largest Clinical Trials unit, a Hair Transplant unit, a Dermal and Laser clinic and a specialist Hair Salon.

We are a globally recognised medical centre led by internationally renowned Dermatologist, Professor Rodney Sinclair. Our main office is conveniently located in East Melbourne with additional centres in Pascoe Vale South & Parkville. DIRECT (Dermatology, Investigational Research, Education & Clinical Trials) is the largest dermatology clinical trials site in Australia.

We run Phases I-IV pharmaceutical sponsored trials, across a range of skin and hair conditions.

About the Role:

The Clinical Trials Sub-Investigator is a medical professional that supports the Principal Investigator and Clinical Trials Management team in the secure, ethical and compliant delivery of dermatology clinical trials. The role provides medical oversight across participant recruitment, pre-screening, informed consent, clinical assessments, treatment and follow-up, including review of medical histories, laboratory results, adverse events and concomitant medications.

The Clinical Trials

Sub-Investigator works closely with Principal Investigators, study coordinators, nurses, sponsors and site staff, the Sub-Investigator. They are expected to lead by example and maintain accurate study documentation, triage and escalate clinical or protocol issues, and protects participant rights, safety, wellbeing, privacy and dignity in accordance with ICH-GCP,



ALCOA++ principles and study requirements.

The Clinical Trials

Sub-Investigator will have opportunities to be involved in clinical research and participate in weekly dermatology clinical meetings and tutorials.

As the Clinical Trials Sub-Investigator, you will:

- Provide medical oversight and participant care for delegated clinical trials, supporting the Principal Investigator to protect participant safety, rights and wellbeing.
- Conduct participant assessments, medical reviews and study visits, including determining eligibility, ongoing suitability and appropriate clinical management.
- Perform and document protocol-required dermatological assessments, including disease severity, efficacy and treatment response evaluations.
- Monitor participant safety, including assessment and management of adverse events, review of pathology and laboratory results, and appropriate escalation of clinical concerns.
- Support participant screening, recruitment, enrolment and retention, ensuring study procedures are completed in accordance with approved protocols and delegated responsibilities.
- Maintain accurate and contemporaneous clinical and research documentation, supporting data integrity, traceability and protocol compliance.
- Conduct delegated responsibilities in accordance with ICH-GCP, TGA requirements, ethical requirements, study protocols and site SOPs.




- Work collaboratively with Principal Investigators, Clinical Trial Coordinators, Research Nurses, Sponsors, CROs, Ethics Committees and healthcare providers to support effective study delivery.
- Participate in investigator meetings, monitoring visits, audits, inspections and quality improvement activities, helping maintain an inspection-ready research setting.
- Provide medical and clinical input into study feasibility, participant management, study start-up and the ongoing development of the Clinical Trials Unit.
- Maintain required AHPRA registration, GCP certification and professional development, while providing clinical guidance and support to research staff.
- Perform all duties within the scope of professional registration, training, experience and documented study delegation, demonstrating professionalism, integrity and a commitment to high-quality clinical research.

About You To be successful in this role, you will have:

- Educational Qualifications: Medical degree recognised by AHPRA. Additional training or certifications in clinical research/trials would be advantageous.
- AHPRA Medical Practitioner Registration including (IMG with current AHPRA registration)
- Experience in Clinical Trials including participant screening, eligibility assessment, informed consent discussions, study visits, protocol-specific procedures, medical reviews, disease assessments and ongoing evaluation of participant suitability for study participation.
- Familiarity with Good Clinical Practice (GCP) guidelines and regulatory requirements is essential.
- Effective communication and can work independently and as part of a team.
- Strong attention to detail.

📌 Clinical Trials Sub-Investigator (East Melbourne)
🏢 Sinclair Dermatology
📍 East Melbourne

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