15 Oct
|
Southern Cross University
|
Melbourne
15 Oct
Southern Cross University
Melbourne
Company Description
At Southern Cross University we strive for excellence. Our game-changing new education models bring a deeper learning experience, improving individual student outcomes and quality of life. We harness the combined forces of compelling research, leading educators and our extraordinary communities to improve the university experience and make a positive impact in the world. Together, we are Transforming Tomorrow.
From a strong evidence-based scientific and multidisciplinary research focus, the National Centre for Naturopathic Medicine (NCNM) is an internationally recognised centre of excellence and innovation in naturopathic medicine education and associated research. The Centre will offer research and education programs, applied research focused on practice-based themes, for health professionals and students, and profession-focused and industry-partnered short courses
(CRICOS Provider: 01241G, TEQSA Provider Code: PRV12043).
Role Description The Research Nurse, Clinical Trials will support the conduct of a clinical device trial involving cancer-diagnosed participants at the Bentleigh East trial site. Working under the lead of A/Prof Janet Schloss and in close collaboration with the NCNM Clinical Trials Manager, Principal Investigators and trial team, the appointee will be responsible for participant management, clinical trial visit coordination, collection of trial data and biological samples, measurement of vital signs, participant monitoring and safety escalation in accordance with the approved protocol, Good Clinical Practice, ethics approval, trial procedures and applicable regulatory requirements.
Key accountabilities
Clinical trial conduct and participant management
- Coordinate participant visits and support day-to-day implementation of the clinical trial at the Bentleigh East site.
- Communicate with participants regarding trial appointments, visit requirements, study procedures and follow-up contacts.
- Support participant screening, enrolment, informed consent processes and ongoing retention in accordance with the approved protocol and delegated responsibilities.
- Maintain professional, respectful and confidential communication with cancer patients and their carers, recognising the sensitivity of the participant group.
- Monitor participants during trial visits and escalate clinical or safety concerns promptly in accordance with the protocol, safety management plan and site procedures.
Clinical procedures and observations
- Undertake trial-related clinical assessments within scope of nursing practice and delegated authority.
- Collect blood samples and other biological samples as required by the protocol and ensure correct labelling, handling, processing, storage and transfer.
- Measure and record vital signs and other clinical observations required for trial assessments.
- Support safe use, monitoring and documentation of the investigational device in accordance with the protocol, device instructions and training requirements.
- Identify and respond to participant distress, clinical deterioration or adverse events in accordance with escalation protocols.
Trial data and documentation
- Collect, enter and verify trial data accurately and contemporaneously in source documents, case report forms and electronic data systems.
- Maintain complete, accurate and auditable participant records in accordance with Good Clinical Practice, privacy requirements and NCNM procedures.
- Ensure protocol-required visit activities, assessments and sample collections are completed within required timeframes.
- Support query resolution, monitoring visits, audit readiness and quality control of study documentation.
- Maintain Investigator Site File.
Safety monitoring and compliance
- Monitor and document adverse events, device-related events and other safety concerns in accordance with protocol requirements and delegated responsibilities.
- Escalate adverse events, serious adverse events, urgent safety matters and protocol deviations to the Principal Investigator, NCNM Clinical Trials Manager and relevant trial personnel in accordance with approved procedures.
- Comply with Good Clinical Practice,
Human Research Ethics Committee approval conditions, trial-specific procedures, participant confidentiality and applicable legislation.
Teamwork and stakeholder liaison
- Work closely with A/Prof Janet Schloss, the Principal Investigators, NCNM Clinical Trials Manager and relevant clinical and administrative staff.
- Participate in site initiation, trial training, team meetings, monitoring activities and study close-out activities as required.
- Liaise professionally with participants, carers, investigators, site personnel, monitors, laboratories and other stakeholders.
- Contribute to the smooth, secure and participant-centred conduct of the trial.
Qualifications and skills required
- Current registration as a Registered Nurse with the Nursing and Midwifery Board of Australia/AHPRA, with relevant clinical nursing experience.
- Demonstrated experience in clinical trials, clinical research, oncology, cancer care or a related clinical setting, or demonstrated capacity to rapidly develop competence in clinical trial conduct.
- Demonstrated ability to undertake participant-facing clinical trial activities, including participant communication, visit coordination, clinical observations, blood collection and accurate documentation.
- Demonstrated understanding of Good Clinical Practice, participant confidentiality, informed consent, protocol adherence and the ethical conduct of research involving human participants.
- Demonstrated ability to monitor participant safety, identify and document adverse events, and escalate clinical or safety concerns appropriately.
- High-level organisational skills, attention to detail and ability to manage protocol-required activities, documentation and timelines accurately.
- Strong interpersonal and communication skills, including the ability to work sensitively and professionally with cancer-diagnosed patients, their carer/s, investigators and multidisciplinary trial teams.
- Ability to work independently within delegated responsibilities while maintaining close communication with the Principal Investigator, NCNM Clinical Trials Manager and trial team.
- Demonstrated commitment to workplace health and safety, cultural safety, equity, privacy and professional nursing standards.
📌 Casual Research Nurse - Clinical Trials (Melbourne)
🏢 Southern Cross University
📍 Melbourne