Clinical Trials Research Nurse Level 2

Research participants and 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 apheresis and cell therapy 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 Cell therapies BaCT)
Health information services department
Human research ethics committee (HREC) and Governance Office (RGO)

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 and ARCS.

• Ensure conduct clinical research trials 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.
• Make appropriate clinical and professional autonomous decisions as required and seek clarification where necessary.
• Provide clinical and professional advice relating to the conduct of clinical research to the Investigators and multidisciplinary team that is in accordance with TGA ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans unit operating procedures and hospital policy.
• Co-ordinate a portfolio of clinicial trials as directed by the team leaders showing the ability to appropriately prioritse workload and seek assistance from team members when required.
• 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.

• Participate in the teaching of nursing & medical staff and other members of the multidisciplinary team in regard to clinical research and associated guidelines & regulations.
• Actively participate in the delivery of the Unit education program.
• Demonstrate 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

• Demonstrate the ability to manage workload to ensure interests of patients on clinical trials are met and protocol requirements are followed.
• Maintain effective communication processes with patients and carers investigators and other members of the multidisciplinary team to ensure information is appropriately shared.
• Work within and monitor standards of care in the defined clinical trial protocols SOPs and practice guidelines of the clinical trials unit hospital policies & procedures to ensure adherence to and delivery of a high quality service.
• Contribute to the development of policies and procedures within the clinical trial unit and organisation to ensure that clinical research practice is underpinned by current best practice.
• Ensure that studies are undertaken in accordance with the terms approved by the institutional ethics committee and TGA. ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans.
• Demonstrates through practice knowledge of ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans.
• Demonstrates knowledge of each designated clinical trial protocol including procedures and documentation to ensure the safe and accurate conduct and recording of the study.
• Be able to provide clinical care as required within their scope of practice and competencies including the ability to administer neoplastic agents if required.
• Use work practice guidelines and study specific documentation to ensure that data is recorded accurately and in accordance with regulatory requirements.
• Screen/register only appropriate patients for clinical trials as per clinical trial eligibility criteria.
• Follow patients as per protocol and where necessary facilitate participant withdrawal from a study in order to ensure the patients best care and the effective achievement of the study aims.
• Show the communication skills necessary to educate and support patients and their carers as they participate in clinical trials and to liaise with the multiple stakeholders involved in clinical trials
• Ensures informed consent is obtained according to standard hospital practice ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans and be actively involved in the ongoing informed consent process.