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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/

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.

Key responsibilities

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

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:

  1. 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.
  2. Preparation of documentation and budgets for ethics and governance submissions.
  3. Preparation of study materials, such as information sheets and advertisements.
  4. Assist in the identification, recruitment, screening, assessment, randomisation and follow up of participating patients, including study specified scheduling of investigations and treatments.
  5. Preparation and maintenance of clinical notes and data entry into electronic case report forms and updating relevant databases.
  6. Liaise with clinical trial sponsors, monitors and associated medical, nursing, pharmacy, imaging and pathology staff.
  7. Willingness to develop within the Clinical Trial Coordinator role, by continuing professional education and attending research and investigator meetings
  8. 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).
  • Academic knowledge or practical experience of clinical trials coordination is preferred.

Desirable

Experience

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

Desirable

Prior to commencement

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

  • Pre-employment National Police Check.

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.

  1. Proven nursing and clinical trials or research experience, preferably including experience in an outpatient setting.
  2. 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.
  3. Experience in project planning and project management, delivery of outcomes, goals, deliverables, assessing work priorities and managing conflicting deadlines.
  4. Demonstrated competency with computer software packages in the Microsoft Office suite, in particular Word, Excel, and Outlook.
  5. 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

Occasionally

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 the CEO

Business Unit: Research Operations and Clinical Trials Support Unit

Position number: P66395

Position title: Clinical Trials Coordinator

Classification: Registered Nurse Level 2

Location: Canberra Hospital

Reporting relationships: Direct Manager: Clinical Trials Manager Manager +1: Director, Research Operations and Clinical Trials

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