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SalaryPOSITION OVERVIEW
The Haematology Clinical Trials Unit provides support for the conduct of clinical research at Canberra Hospital. The Unit currently has active trials in varying stages ranging from ethics submissions to trial close outs. These trials are either Pharmaceutical Sponsored trials, Registries, Investigator Led trials or Collaborative Studies that are funded by grants such as the Australasian Leukaemia and Lymphoma Group (ALLG).
The Clinical Trials Coordinators provide key support to, and coordination of clinical research projects undertaken by the Haematology 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 Haematology. 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 of Haematology Clinical Trials, the Clinical Haematologists, and the Clinical Trials Manager.
DUTIES
Under limited direction of the Clinical Trials Manager, you will perform Clinical Trial Co-ordinator duties for the Haematology 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.
- 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 contribute to the operation of the organisation.
ABOUT YOU
Behavioural Capabilities
- 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.
Position Requirements/Qualifications:
- SRO1 - A degree in a relevant area, from a recognised university AND significant subsequent clinical trials experience. These positions will be offered based on the extent of applicants demonstrated clinical trials experience and expertise.
- The successful applicant will need to be available for occasional after-hours work.
- Have an understanding of how the National Statement on Ethics Conduct in Human Research aligns with this role.
- 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.
- Have an understanding of how the National Standards and Quality Health Service (NSQHS) indicators align with this role.
- Fulfil the responsibilities of this role as detailed in the CHS Exceptional Care Framework, Clinical Governance Framework, Partnering With Consumers Framework and all other related frameworks.
Prior to commencement successful candidates will be required to:
- Undergo a pre-employment National Police Check.
- Obtain a Compliance Certificate from OMU (Occupational Medicine Unit) relating to assessment, screening, and vaccination processes against specified infectious diseases.
WHAT YOU REQUIRE
These are the key selection criteria for how you will be assessed in conjunction with your resumé and experience:
- Proven clinical trials or research experience, preferably including experience in an outpatient setting.
- 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.
- Experience in project planning and project management, delivery of outcomes, goals, deliverables, assessing work priorities and managing conflicting deadlines.
- Demonstrated competency with computer software packages in the Microsoft Office suite, in particular Word, Excel, and Outlook.
- Demonstrates understanding of, and adherence to, safety and quality standards, work, health, and safety (WH&S) and the positive patient experience. Displays behaviour consistent with CHS’s values of reliable, progressive, respectful, and kind.
HOW TO APPLY / OR WANT TO KNOW MORE?
Applications must be submitted through the e-recruitment system. Applications must include:
A copy of a current curriculum vitae
A response to the selection criteria under “What You Require” found within the position description and should be no more than 2 sides of A4 in length.
