Position overview
Canberra Health Services (CHS) is focussed on the delivery of high quality, effective, person-centred care. It provides acute, sub-acute, primary, and community‐based health services to the Australian Capital Territory (ACT) and surrounding region. More information can be found on the CHS website: https://www.health.act.gov.au/
Research Operations and Clinical Trials Support Unit (ROCTSU) provides support for the conduct of clinical trials and research programs and projects across Canberra Health Services (CHS). The ROCTSU provides support for the conduct of clinical research in Canberra Health facilities including but not limited to Canberra Hospital, North Canberra Hospital, University of Canberra Hospital, and community health facilities. The ROCTSU participates in local and national clinical trials and research programs and projects and has active trials in varying stages ranging from regulatory submissions to trial close out. The number of participants in each trial varies from 1 to over 1000. The ROCTSU supports programs and projects across all sponsor types including pharmaceutical industry, collaborative group and investigator initiated clinical trials projects and programs that are funded through grants. The ROCTSU works closely with the Research Ethics and Governance Office to ensure safe and high-quality trial conduct.
The Clinical Trials Coordinators provide key support to, and coordination of clinical research projects undertaken by the Central Clinical Trials Unit at Canberra Hospital. The projects will vary and may involve the evaluation of novel therapies in Phase 3, 2 and 1 Trials in the fields of malignant and non-malignant Central. The main responsibilities of the Clinical Trials Coordinator will be to act as “key” person for all aspects of the planning, conduct, implementation, and management of a clinical trial including ethics and governance approvals, contractual and regulatory management in collaboration with other clinical trial staff as well as co-ordinating patient care. They will act as a contact person responsible for ensuring milestones are achieved and conduct of the trial is compliant with Good Clinical Practice. Their work is under the general direction of the Principal Investigator, Director of Research Operations and Clinical Trials and the Clinical Trials Manager.
Key responsibilities
Specific responsibilities include, but are not limited to, the following.
Under limited direction of the Lead Clinical Trials Coordinator, you will perform Clinical Trial Co-ordinator duties for the Central Clinical Trials Unit. You will be responsible for:
- The co-ordination and daily conduct of Multicentre Phase 1, Phase 2 and Phase 3 clinical trials, and local research in collaboration with local Investigators.
- Preparation of documentation and budgets for ethics and governance submissions.
- Preparation of study materials, such as information sheets and advertisements.
- Assist 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.
- Liaise with clinical trial sponsors, monitors and associated medical, nursing, pharmacy, imaging and pathology staff.
- Willingness to develop within the Clinical Trial Coordinator role, by continuing professional education and attending research and investigator meetings
- Undertake other duties appropriate to this level of classification which contribute to the operation of the organisation.
Competencies
Specific responsibilities include but are not limited to the following.
- Displays critical thinking skills and forms defensible conclusions based on evidence and sound judgement
- Adaptability and flexibility to accommodate change and provide responsive services to meet clients’ needs
- Strong organisational skills with a strong work ethic
- Sound written and oral communication skills and works well individually and in a team environment.
Qualifications
Specific responsibilities include, but are not limited to, the following.
Essential
- Be registered or be eligible for registration as a Nurse with the Australian Health Practitioner Regulation Agency (AHPRA).
Desirable
- Have an understanding of how the National Safety and Quality Health Service (NSQHS) indicators align with this role.
- Academic knowledge or practical experience of clinical trials coordination is preferred.
Experience
Specific responsibilities include, but are not limited to, the following.
Essential
- A minimum 4 years’ work experience as a Registered Nurse.
Desirable
- Project Management experience
- Experience or knowledge of the CHS Exceptional Care Framework, Clinical Governance Framework, Partnering With Consumers 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.
- 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.
- Be available for weekend and/or after-hours work.
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.
- Proven nursing experience with either experience in or the ability to rapidly acquire the skills required to coordinate clinical trials or research activities within a healthcare setting, including managing patient care and ensuring compliance with ethical, policy, protocol and regulatory standards.
- Exceptional interpersonal and communication skills, with a proven ability to build and maintain effective relationships with patients, investigators, sponsors, and multidisciplinary teams, while conveying complex information clearly in both verbal and written formats.
- Demonstrated capability in end-to-end project coordination, including planning, prioritising, and delivering trial milestones within strict timelines, managing competing priorities, and resolving challenges in a dynamic clinical environment.
- High-level proficiency in digital tools and clinical trial management systems, including advanced use of Microsoft Office applications (Word, Excel, Outlook) and the ability to quickly adapt to new technologies to support data integrity and reporting requirements.
- 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.
Administrative | Frequency |
|---|---|
Telephone use | Frequently |
General computer use | Frequently |
Extensive keying/data entry | Frequently |
Graphical/analytical based | Frequently |
Sitting at a desk | Frequently |
Standing for long periods | Occasionally |
Travel | Frequency |
|---|---|
Frequent travel – multiple work sites | Occasionally |
Frequent travel – driving | Occasionally |
Physical demands | Frequency |
|---|---|
Distance walking (large buildings or inter-building transit) | Frequently |
Working outdoors | Never |
Psychosocial demands | Frequency |
|---|---|
Distressed People e.g. Emergency or grief situations | Never |
Aggressive & Uncooperative People e.g. drug / alcohol, dementia, mental illness | Never |
Unpredictable People e.g. Dementia, mental illness, head injuries | Never |
Restraining e.g. involvement in physical containment of clients/consumers | Never |
Exposure to Distressing Situations e.g. Child abuse, viewing dead / mutilated bodies; verbal abuse; domestic violence; suicide | Never |
Specific hazards | Frequency |
|---|---|
Working at heights | Never |
Exposure to extreme temperatures | Never |
Operation of heavy machinery e.g. forklift | Never |
Confined spaces | Never |
Excessive noise | Never |
Low lighting | Never |
Handling of dangerous goods/equipment e.g. gases; liquids; biological. | Never |
Slippery or uneven surfaces | Never |
Manual handling | Frequency |
|---|---|
Lifting 0 – 9kg | Occasionally |
Lifting 10 – 15kg | Never |
Lifting 16kg+ | Never |
Climbing | Never |
Running | Never |
Reaching | Never |
Kneeling | Never |
Foot and leg movement | Occasionally |
Hand, arm and grasping movements | Occasionally |
Bending/squatting | Occasionally |
Bend/Lean Forward from Waist/Trunk twisting | Occasionally |
Push/pull | Occasionally |
Sequential repetitive movements in a short amount of time | Never |
Directorate: CHS
Division: Office of Research and Education
Business Unit: Research Operations and Clinical Trials Unit
Position number: P58243
Position title: Clinical Trials Coordinator – Central Clinical Trials Unit
Classification: Registered Nurse Level 2
Location: The Canberra Hospital
Reporting relationships: Direct Manager: Lead Clinical Trials Coordinator Manager +1: Clinical Trials Manager