Position overview

This position is located at Canberra Region Cancer Centre, Canberra Hospital onsite with scope for hybrid work arrangements for special circumstances.

The Radiation Oncology Department at the Canberra Region Cancer Centre provides state-of-the-art radiotherapy treatment facilities and high-quality care for cancer patients across the ACT and surrounding regions. The Radiation Oncology Clinical Trials Unit supports the conduct of clinical research within the department, contributing to advancements in cancer treatment and patient care.

The Clinical Trial Coordinator plays a pivotal role in supporting and coordinating clinical research projects within the Radiation Oncology Clinical Trials Unit reporting to the Senior Clinical Trials Co-ordinator. These projects include:

• Collaborative studies with the Trans-Tasman Radiation Oncology Group (TROG).
• Pharmaceutical-sponsored trials.
• Investigator-led studies in Phase I, II, and III oncology trials.
• Collaborations with the ANU/John Curtin School of Medical Research iCube Laboratory.
• Low-risk projects, including medical student research initiatives.

This role entails coordinating all aspects of clinical trial planning, implementation, and management, managing ethics and governance submissions, regulatory compliance, and contractual requirements. The clinical trials coordinator acts as the primary contact for trial-related communication from sponsors, collaborating with Principal Investigators, Radiation Oncologists, and members of the research team. The clinical trial coordinator, together with the entire research team is responsible for upholding Good Clinical Practice (GCP) standards.

This position operates under the general direction of the Director of Research, Radiation Oncology Clinical Trials and works closely with Principal Investigators with other clinical trial staff with regular interaction with the entire multi-disciplinary team in the Radiation Oncology department. The line-manager is the senior clinical trials co-ordinator.

Key Responsibilities

Under limited direction of the senior research officer and Director of Research Radiation oncology and in co-operation with colleagues in the Radiation Oncology Clinical Trial Unit, you will be responsible for:

1. 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.
2. 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.
3. Preparation of documentation and budgets for ethics and governance submissions.
4. Preparation of study materials, such as information sheets and advertisements.
5. Assisting in the identification, recruitment, screening, assessment, randomisation and follow up of participating patients, including study specified scheduling of investigations and treatments.
6. Preparation and maintenance of clinical notes and data entry into electronic case report forms and updating relevant databases.
7. Liaising with clinical trial sponsors, monitors and associated medical, nursing, pharmacy, imaging, and pathology staff.
8. Demonstrating a willingness to develop within the Clinical Trial Coordinator role, by continuing professional education and attending research and investigator meetings.
9. Undertake other duties appropriate to this level of classification which contribute to the operation of the organisation, for example, role as meeting secretariat for Research Meetings.
10. The successful applicants will need to be available for occasional after-hours work.

Competencies

Specific competencies include but are not limited to the following.

• Have an understanding of how the National Statement on Ethics Conduct in Human Research aligns with this role.
• Have an understanding of how the National Safety and Quality Health Service (NSQHS) indicators align with this role.

Qualifications

Specific qualifications include, but are not limited to, the following.

Essential

• 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. Academic knowledge or research experience is preferred.

Desirable

• GCP certification will be required prior to commencing in the role (if not already current at the time of the interview).

Experience

Specific experience includes but is not limited to the following.

Essential

• Experience in co-ordinating clinical trials and/or experience in a medical research environment.
• Experience that demonstrates high-level communication and organisational skills.
• Experience and references illustrating high-level attention to detail.

Desirable

• Meeting secretarial experience.
• 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:

• Undergo a pre-employment National Police Check.
• Prior to commencing this role, a 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.

What you Require (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.
2. Demonstrated understanding of Good Clinical Practice as it applies to conduct of clinical trials.
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 conflicting deadlines.
5. Demonstrated 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 (WH&S) and positive patient experience. Displays behavior 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.