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
Research Nurse Level 2, or Study Coordinator
- Full Time, Ongoing (80 hours per fortnight with an accrued day off once per month)
- Parkville location with flexible, hybrid working
- $111,930 (Research Nurse) $90,235.60 - $103,724.40 (Study Coordinator) salary range + salary packaging + super + 5 weeks annual leave
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 Womens' Hospital. We are the largest oncology trials unit in Australia with an exciting and expanding trials portfolio.
Our focus on early phase trials means that we are seeking a research nurse or study coordinator, with medical oncology/haematology experience in clinical trials to join our team. The successful candidate will have clinical trial experience in a hospital and excellent communication skills. They will also be a team player with great time management skills.
For an experienced candidate a senior research nurse or senior study coordinator position will be considered. For the full selection criteria, please see the PD.
The position is full time, ongoing.
Working within a team, the Clinical Trials Research Nurse (level 2) or Study Coordinator 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.
Position Summary
This role will be responsible for the conduct of Clinical Trials within in the Department of Haematology & Medical Oncology.
The Clinical Trials Research Nurse 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
Immunisation Risk Category
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)
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| 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.
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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.
- 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.
- Research experience including working knowledge of Australian and International statutory and regulatory requirements including - TGA, FDA, EMEA
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| 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.
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Certifications, Licenses & Registrations
Key Accountabilities
| Key Accountabilities |
Demonstrated by / Key Performance Indicators |
| 1. To effectively manage 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.
- 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 National Statement on Ethical Conduct in Research Involving Humans, unit operating procedures & 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.
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| 2. To undertake and participate in professional development and education |
- 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.
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Key Accountabilities (Contd..)
| 3. Ensure quality data and patient safety at all times |
- 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 & 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.
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| 4. To function as an integral member of the clinical research team |
- Develops & participates in appropriate quality activities.
- Participates in unit meetings.
- Takes responsibility for ensuring trial patients are only seen and managed by appropriately delegated members of the trial staff provide care to patients and their carers in the case of the primary Research nurse’s absence and ensure that protocol requirements are carried out according to protocol and without incident.
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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.
