Research Nurse Level 3 Clinical Trials

EXCELLENCE

We ensure clinical practice is evidence-based patient-centred and provided by qualified and experienced staff.

COMPASSION

We adhere to the strongest ethical standards to ensure a culture of openness mutual respect and trust.

INNOVATION

We strive to ensure that innovation is fostered by supporting research and a learning culture.

• Research participants & their caregivers.
• Multidisciplinary team members.
• Clinical Trials Unit Staff.
• All Peter Mac Clinical Research staff.
• Clinical nurses in all relevant patient care areas - including SDS OPD ward nurses diagnostic imaging nurses Principal Investigators Co-investigators and associated clinical trial medical staff.
• Departments implicated in clinical research external to CTU (pathology diagnostic imaging nuclear medicine pharmacy BaCT).
• Health information services department.
• Internal human research ethics committee (HREC).

• Clinical Trial Sponsor representatives from pharmaceutical companies and collaborative groups.
• Cancer Trials Australia.
• Research nurses and data managers at other hospitals.
• External laboratories and diagnostic imaging centres.
• Professional bodies such as VCOG & COSA & ARCS.

• Current registration with the Nurses Board of Victoria with a minimum of 3 years post graduate oncology and/or haematology nursing experience or relevant experience demonstrating the appropriate competencies and skills for the job and clinical setting.
• Degree level education or other relevant further education.
• Personal integrity and discretion.
• Demonstrated excellent team working skills with ability to work using own initiative.
• Effective listening and interpersonal skills.
• Time management skills and the ability to prioritize workload.

• Evidence of further education including post-graduate certification/diploma/continuous professional development specific to oncology/haematology and/ or clinical research.
• Comprehensive IT skills.
• Clinical trials experience including working knowledge of Australian and International statutory and regulatory requirements including - TGA FDA EMEA

• Ensure clinical research trials conduct is in accordance with TGA ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans.
• Practice at all times within current appropriate state and federal regulations and hospital policy.
• Able to make appropriate clinical and professional autonomous decisions as required & seek clarification where necessary.
• Provide clinical & professional advice relating to the conduct of clinical research to the Investigators & multidisciplinary team that is in accordance with TGA ICH GCP and the NHMRC NationalStatement on Ethical Conduct in Research Involving Humans unit operating procedures & hospital policy.
• Maintain a flexible approach to working hours in order to meet the requirements of research protocols and subject recruitment.
• Liaise with all involved groups/departments to ensure all biological samples are collected processed stored and shipped as per the clinical trial protocol requirements.
• Participate in clinical trial monitoring/auditing internally and externally as required in order to meet the regulatory and scientific requirements.
• Work effectively with pharmaceutical company representatives (CRAs) during monitoring of clinical trial data internal company audits and external reviews.

• ffectively manage clinical trial workloads to prioritise patient safety wellbeing and protocol compliance.
• Maintain clear communication with patients carers investigators and multidisciplinary teams to ensure effective information sharing.
• Adhere to clinical trial protocols SOPs practice guidelines hospital policies and regulatory requirements to deliver high-quality research.
• Contribute to the development and review of policies and procedures to support best-practice clinical research.
• Ensure studies comply with ethics committee and TGA approvals ICH-GCP and the NHMRC National Statement on Ethical Conduct in Human Research.
• Demonstrate sound knowledge of clinical trial protocols study procedures eligibility criteria documentation and regulatory requirements.
• Accurately document and manage clinical trial data in accordance with protocol and regulatory standards.
• Appropriately screen enrol monitor and withdraw participants in accordance with eligibility criteria and study protocols while prioritising optimal patient care.
• Ensure informed consent is obtained and maintained in accordance with hospital policies ICH-GCP and NHMRC requirements.

• Participate in the teaching of nursing & medical staff and other members of the multidisciplinary team in regard to clinical research and associated guidelines & regulations.
• Demonstrates a commitment to personal continuing professional development and participate in performance review/appraisal.
• Undertakes additional training in order to acquire the knowledge and skills needed to implement new study protocols from a variety of clinical specialties.
• In conjunction with preceptor educator & manager identify areas that require additional knowledge and work towards meeting the learning objectives set.
• Maintain up-to-date clinical skills and knowledge delivering care to allocated study clinical trial patients.
• Maintain mandatory training requirements as defined by hospital and nursing policy.

• Participates in appropriate quality activities.
• Participates in unit meetings.
• Takes responsibility for ensuring trial patients are seen in primaryResearch nurses absence and protocol requirements are carried out according to protocol and without incident.