Research Nurse Level 2 – Clinical Trials
Unit: EDD
Division: Chief Operating Officer
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
* Salary: $111,930 (Research Nurse) or $90,235.60 – $103,724.40 (Study Coordinator) + salary packaging + super + 5 weeks annual leave
The Parkville Cancer Clinical Trials Unit (PCCTU) coordinates 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.
About the Role
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) Guidance on Good Clinical Practice (GCP) 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 the Department of Haematology & Medical Oncology.
Classification or Salary Range: YU13
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 and ARCS.
Education
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.
Skills
* 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 prioritise workload.
* Research experience including working knowledge of Australian and International statutory and regulatory requirements (TGA, FDA, EMEA).
* Evidence of further education including post-graduate certification/diploma/continuous professional development specific to oncology/haematology and/or clinical research.
Key Accountabilities
1. To effectively manage clinical research trials
* Ensure conduct of 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.
* Co‑ordinate a portfolio of clinical trials as directed by the team leaders, showing the ability to prioritise workload.
* Maintain a flexible approach to working hours to meet protocol and recruitment requirements.
* Liaise with all involved groups/departments to ensure biological samples are collected, processed, stored and shipped according to protocols.
* Participate in clinical trial monitoring/auditing internally and externally.
* Work effectively with pharmaceutical company representatives (CRAs) during monitoring.
2. To undertake and participate in professional development and education
* Participate in the teaching of nursing, medical staff and other multidisciplinary team members regarding clinical research and 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.
* Undertake additional training to acquire the knowledge needed to implement new study protocols.
* Identify areas that require additional knowledge and work towards learning objectives with preceptor, educator & manager.
* Maintain up‑to‑date clinical skills and knowledge for allocated study patients.
* Maintain mandatory training as defined by hospital and nursing policy.
3. Ensure quality data and patient safety at all times
* Manage workload to ensure patient interests and protocol requirements are met.
* Maintain effective communication with patients, carers, investigators, multidisciplinary team.
* Work within and monitor standards of care and SOPs to ensure high quality service.
* Contribute to development of policies and procedures within the clinical trial unit.
* Ensure studies are undertaken in accordance with ethical and regulatory approvals.
* Demonstrate knowledge of GCP and NHMRC ethical principles.
* Know each clinical trial protocol, procedures, documentation.
* Provide clinical care within scope, including administration of neoplastic agents if required.
* Use guidelines and documentation to record data accurately and per regulatory requirements.
* Screen and register only appropriate patients; follow and support participants per protocol.
* Educate and support patients and carers during trials.
* Ensure informed consent obtained per standard practice and GCP/ethical guidelines.
4. To function as an integral member of the clinical research team
* Develop and participate in relevant quality activities.
* Participate in unit meetings.
* Ensure trial patients are managed by appropriately delegated staff when primary nurse is absent, ensuring protocol adherence.
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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 offers 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.
The Peter MacCallum Cancer Centre acknowledges the traditional owners of the land on which our five sites are located throughout Victoria. We recognise their strength and resilience and pay our respects to their Elders past and present.
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