Position overview

The Radiation Oncology Department is located at the Canberra Region Cancer Centre at The Canberra Hospital and provides state-of-the-art radiotherapy treatment facilities combined with quality care for ACT and regional cancer patients. The department is committed to advancing cancer treatment through clinical research and innovation.

The Radiation Oncology Clinical Trials Unit provides support for the conduct of clinical research within the Radiation Oncology Department at The Canberra Hospital. This senior coordinator has a shared office in the Canberra Hospital Radiation Oncology Department. Hybrid work arrangements will be considered for special circumstances.

A Senior Clinical Trial Coordinator oversee all aspects of trial planning, initiation, conduct, and close-out, manage ethics and governance submissions, regulatory documentation, and contractual agreements, act as the primary contact for trial stakeholders, ensuring milestones are met and compliance with GCP standards, and support collaboration with TROG, pharmaceutical sponsors, and investigator-led studies. The Radiation Oncology Clinical trials team coordinate a diverse range of studies, including Trans-Tasman Radiation Oncology Group (TROG) trials, pharmaceutical-sponsored research, and investigator-led Phase I–III oncology trials, collaborative studies with the I-CUBE laboratory at ANU, and low-risk studies supporting radiation oncology student and registrar projects.

In addition to clinical trial co-ordination duties, the Senior Clinical Trials Coordinator is responsible for team coordination, including rostering, leave management, timesheet oversight, and workload distribution. The senior coordinator contributes to Strengths, Education and Development (SED) Plans in collaboration with the Director of Research in Radiation Oncology. There is an expectation that the senior clinical trials coordinator is a leader in process improvement and strives to see how things can be done better, bringing the team and stakeholders along with them.

The role reports to the Research Director of Radiation Oncology and works closely with Principal Investigators and Radiation Oncologists.

Key Responsibilities

Under limited direction of the Director of Research Radiation oncology and in co-operation with staff from the Radiation Oncology Clinical Trial Unit, you will perform Clinical Trial Coordinator duties while managing a small team. You will be responsible for:

• In collaboration with the Director of Research, Radiation Oncology, day-to-day co-ordination of the clinical trials team, such as basic rostering, leave cover, timesheet checking, and workload distribution.
• The co-ordination and daily conduct of Multicenter Phase 1, Phase 2 and Phase 3 clinical trials, and local research in collaboration with local Investigators.
• Support the Principal Investigators in the planning and conduct of clinical trials to ensure compliance with the protocol and legislative and policy requirements in line with Good Clinical Practice.
• Preparation of documentation and budgets for ethics and governance submissions.
• Preparation of study materials, such as information sheets and advertisements.
• Assisting in the identification, recruitment, screening, assessment, randomisation and follow up of participating patients, including study specified scheduling of investigations and treatments.
• Preparation and maintenance of clinical notes and data entry into electronic case report forms and updating relevant databases.
• Liaising with clinical trial sponsors, monitors and associated medical, nursing, pharmacy, imaging, and pathology staff.
• Demonstrating a willingness to develop within the Clinical Trial Coordinator role, by continuing professional education and attending research and investigator meetings.
• Undertaking other duties appropriate to this level of classification which contributes to the operation of the organisation, including project work driving integration of clinical trials and data management processes with the Digital Health Record.

Competencies

• CHS is leading the drive to digitally transform health service delivery in Australia through the implementation of a territory wide Digital Health Record. Computer literacy skills are required which are relevant to this role as you will be responsible for completing required documentation and becoming a proficient user of the Digital Health Record and/or other Information Technology systems; once proficient, you will need to remain current with changes, updates, and contingencies.
• Ability to drive process improvement using practical and technological solutions.
• Strong organisational skills and a good work ethic.
• Excellent written and oral communication skills.
• Team building and conflict resolution skills.
• Understand how the National Safety and Quality Health Service (NSQHS) indicators align with this role.
• Understand how the National Statement on Ethics Conduct in Human Research aligns with this role.
• Excellent organisational, communication, and problem-solving skills.
• Ability to work independently and as part of a multidisciplinary team.
• Fulfil the responsibilities of this role in alignment to the CHS Exceptional Care Framework, and all other related frameworks.

Qualifications

Essential

• Relevant tertiary qualifications in health sciences, nursing, or clinical research, or a degree in a relevant area, from a recognised university with significant subsequent relevant work experience, OR an equivalent combination of experience and/or education.

Desirable

• Good Clinical Practice Certification (mandatory if offered the position).
• Completion of Digital Health Record courses relevant to the Canberra Health Services.

Experience

Essential

• Leadership in process improvement.
• Management experience.
• Experience demonstrating high-level communication and organisational skills.
• Experience and references illustrating high-level attention to detail.
• Demonstrated experience in clinical trial coordination, preferably in oncology.
• Strong understanding of GCP, ethics, and regulatory requirements.

Desirable

• Two or more years working as a clinical trials coordinator.
• Experience working in a Radiation Oncology Clinical Unit.
• Skills in financial management.
• Project management skills.
• Experience or knowledge of the CHS Exceptional Care Framework and all other related frameworks.

Prior to commencement

Appointment to this position is conditional on being granted and retaining appropriate clearances:

• Pre-employment National Police Check.
• Current registration issued under the Working with Vulnerable People (Background Checking) Act 2011 is required.
• Comply with Canberra Health Services Occupational Assessment, Screening and Vaccination policy.

Important information

All employees are required to:

• Adhere to the Canberra Health Services Values and the ACT Public Service Code of Conduct.
• Act in accordance and comply with all relevant Safety and Quality policies and procedures.
• Comply with all relevant clinical and/or competency standards.

CHS is leading the drive to digitally transform health service delivery in Australia through the implementation of a territory wide Digital Health Record. Computer literacy skills are required which are relevant to this role as you will be responsible for completing required documentation and becoming a proficient user of the Digital Health Record and/or other Information Technology systems; once proficient, you will need to remain current with changes, updates, and contingencies.

Key Selection Criteria

These are the key selection criteria for how you will be assessed in conjunction with your resumé and experience.

1. Proven clinical trials or research experience, preferably including experience in an outpatient setting. Demonstrated understanding of Good Clinical Practice as it applies to conduct of clinical trials.
2. Experience or aptitude in managing staff to accomplish unit goals with an understanding of strategies to distribute workloads between staff.
3. Demonstrated ability to communicate verbally and in writing with patients, the clinical trials team, and multidisciplinary groups and establish relationships with internal and external stakeholders.
4. Experience in project planning and project management, delivery of outcomes, goals, deliverables, assessing work priorities, and managing conflict deadlines.
5. Demonstrated high-level competency with computer software packages in the Microsoft Office suite, in particular Word, Excel, and Outlook.
6. Demonstrates understanding of, and adherence to, safety and quality standards, Work Health and Safety and the positive patient experience. Displays behaviour consistent with CHS’s values of reliable, progressive, respectful, and kind.

Work Environment Description

The following work environment description outlines the inherent requirements of the role and indicates how frequently each of these requirements would need to be performed. Please note that the ACT Public Service is committed to providing reasonable adjustments and ensuring all individuals have equal opportunities in the workplace.