At Peter Mac we aim to continuously improve cancer care, research and education across all cancers and for all people affected by cancer: changing lives, breaking new ground. Everything we do is underpinned by our core values, Excellence, Compassion and Innovation. Welcoming people from a wide variety of different backgrounds and experiences is critical to fostering innovation, cultivating compassion, attracting and retaining top talent and providing the best possible cancer care for our patients.
YOUR ROLE IN OUR FUTURE
The Parkville Cancer Clinical Trials Unit (PCCTU) co-ordinates clinical trials across the 3 institutions of the Parkville Medical precinct: The Peter MacCallum Cancer Centre, the Royal Melbourne Hospital and the Royal Women’s Hospital. We are the largest oncology trials unit in Australia with an exciting and expanding trials portfolio. We are seeking a nurse with oncology experience who is eager to experience the world of clinical trials to join our Lung, Colorectal and Palliative Care team. The successful candidate will have clinical experience in a hospital, excellent communication skills and a willingness to learn. The position is full time, fixed term for 2 years with the potential for permanency. Applicants seeking part-time employment will be considered. Training and mentoring are provided.
Applicants to this role should provide a covering letter outlining relative key skills and experience to assist us with our assessment.
For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position summary. Alternatively, please contact us using the information below for a confidential discussion.
Under supervision, the Clinical Trials Research Nurse (level 1) will coordinate the delivery of direct and indirect care and associated data collection for concurrent research studies undertaken in the department, in accordance with the Therapeutic Goods Administration (TGA) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) and the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Research Involving Humans.
Enterprise Agreement
Nurses and Midwives (Victorian Public Sector) (Single Interest Employers) EnterpriseAgreement 2020-2024.
Classification or Salary Range
Research Nurse Level 1
Immunisation Risk Category
Immunisation Category A
Key Relationships
Internal
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).
External
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.
Education
Skills
Essential Requirements
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.
Problem solving skills.
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.
Desirable Requirements
Evidence of further education including post-graduate certification/diploma/continuous professional development specific to oncology/haematology and/ or clinical research.
Comprehensive IT skills.
Any previous research experience including working knowledge of Australian and International statutory and regulatory requirements including - TGA, FDA, EMEA
Certifications, Licenses & Registrations
AHPRA Registration
Key Accountabilities
Key Accountabilities
Demonstrated by / Key Performance Indicators
1. To effectively co-ordinate clinical research trials
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.
Able to make appropriate clinical and professional autonomous decisions as appropriate to their current level of experience & seek clarification from senior colleagues where necessary.
Within their scope and level of competency, provide advice on the clinical aspects of a trial protocol to the Investigators & multidisciplinary team that is in accordance with TGA ICH GCP and the NHMRC National Statement on Ethical Conduct in Research involving Humans and in line with hospital policies and best clinical practice.
With supervision, provide advice on the regulatory and co-ordination aspects of a trial protocol to the Investigators & multidisciplinary team that is in accordance with ICH GCP and the NHMRC National Statement .
Work within the regulatory guidelines of the NHMRC Statement 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.
Develop an effective working relationship with pharmaceutical company representatives (CRAs) during monitoring of clinical trial data, internal company audits and external reviews.
2. To undertake and participate in professional development and education
Undertake ICH GCP training, and PCCTU departmental mandated education modules and within the specified timelines fulfil the competencies listed in the PCCTU Clinical research nurse competency framework.
Participate in the teaching of nursing & medical staff and other members of the multidisciplinary team in regard to clinical research and associated guidelines & regulations in conjunction with senior colleagues.
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, including neoplastic agent administration competency if this has not already been undertaken.
Key Accountabilities (Contd..)
3. Ensure quality data and patient safety at all times
Gain expertise 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.
Always involve patients and their carers in decisions related to their care.
Work within the 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 and seek guidance from senior colleagues as required.
Provide clinical care as required within their scope of practice and level of competency, including the administration of chemotherapy and other neoplastic agents if so trained.
Using existing clinical skills and expertise, contribute to the development of policies and procedures within the clinical trial unit & organisation to ensure that clinical practice within the trials unit 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. Develop a knowledge of ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involing Humans and seek guidance from senior colleagues as required.
Develop a knowledge of each designated clinical trial protocol including procedures and documentation to ensure the safe and accurate conduct and recording of the study and seek guidance from senior colleagues as required.
Use practice guidelines and study specific documentation to ensure that data is recorded accurately and in accordance with regulatoryand privacy requirements.
Develop the ability to 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.
Ensure 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.
4. To function as an integral member of the clinical research team
Participates in appropriate quality activities.
Participates in unit meetings.
Takes responsibility for ensuring trial patients are seen by members of the delegated trial teams for trial visits. Take responsibility for ensuring protocol requirements are carried out in the absence of the trial co-ordinator/research nurse, seeking guidance from senior staff as required.
For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position profile. Alternatively, please contact us for a confidential discussion.
Peter Mac is a child safe organisation and has a commitment to child safety and wellbeing.
WHY WORK FOR PETER MAC
Peter Mac offer a range of benefits which support our people both personally and professionally.
Our staff benefits include award winning facilities, professional development and events, a health and wellbeing program, flexible work practices and policies and financial benefits such as salary packaging.
We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQI community and people with a disability.
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