SCHN Clinical Trials Start-Up Officer

The Sydney Children's Hospitals Network; Sydney; Vor Ort; AUD 91.000 - 121.000; Vollzeit

Benefits dieser Stelle

Flexible work opportunities

Salary packaging

Meal entertainment benefits

Accrued days off (ADOs)

Fitness passport

Employee assistance program (EAP)

Zusammenfassung

The Sydney Children’s Hospitals Network is seeking a Clinical Trials Start-Up Officer to support and coordinate study start-up activities across SCHN sites CHW & SCH. You will work with sponsors, investigators, and departments to ensure timely governance authorisation and documentation.

The role focuses on start-up administration, CTMS support, financial management for start-up, and maintaining strong collaborative relationships to meet study timelines in a busy clinical research environment.

Qualifikationen

• Relevant tertiary qualifications in a relevant field, or equivalent work experience with study start up or clinical trial management in a clinical research environment, or a combination of study and work experience.
• Demonstrated knowledge of legislation and guidelines for conducting clinical trials in Australia.
• Experience in obtaining and maintaining ethics and governance approvals.
• Ability to meet study start up deadlines and manage competing priorities with attention to detail.

Aufgaben

• Support study start up activity from initial site approach through to RGO authorisation.
• Draft and finalise HREA, SSA, ICFs and IDAs according to timelines.
• Review study documentation to local ethics or governance requirements.
• Provide financial management support related to start up.
• Conduct efficient and accurate handovers to clinical teams.
• Complete minimum data set fields in CTMS and create protocol notes for updates.
• Support CTMS builds and log expenditures; create SOWs in CTMS.

Kenntnisse

Autonomy & initiative

Problem solving

Time & workload management

Attention to detail

Interpersonal communication

Written communication

Strong computer skills

Independent & collaborative work

Ausbildung

Relevant tertiary qualifications or equivalent

Jobbeschreibung

Employment Type: Temporary Full Time until 22 November 2027 Position Classification: Health Mgr Lvl 1 Remuneration: 91326 - 121497 full-time equivalent base salary range (+12% super + 17.5% leave loading and salary packaging) Hours Per Week: 38 Requisition ID: REQ703419 Location: Network Applications Close: Midnight on 8 November 2026 For role related queries or questions contact Natasha Edirisinghege on [e-mail]

At the Sydney Children's Hospitals Network, every role helps children and young people live their healthiest lives. As the largest paediatric health service in Australia, we care for thousands of children each year, in hospital and at home. Our people are united by compassion, collaboration and excellence in care. The Clinical Research Centre's (CRCs), located at both The Children’s Hospital at Westmead (CHW) and the Sydney Children’s Hospital (SCH), conduct a wide variety of clinical research through a network of researchers and health professionals across the SCHN. Under the umbrella of Kids Research, the CRCs aim to translate new evidence into clinical care and treatment at both sites.

THE ROLE:

Supporting and completing ongoing study amendments Supporting feasibility assessments where required. The Clinical Trials Start-Up Officer will work across both SCHN sites, CHW & SCH, to support clinical research start up activities, specific to the CRCs. This role encompasses supporting administrative functions in clinical research and the broader organisational unit, while fostering strong, professional relationships with sponsors, investigators, supporting departments, collaborators, and their teams through clear, consultative communication.

General Responsibilities:

• Provide continued support and encourage collaboration within the CRC start up team
• Support the development and implementation of start-up systems and processes within the CRC Build and maintain relationships with supporting departments
• Display high standards of accuracy and prioritisation, in line with study start up timelines
• Undertake additional duties aligned with the role’s classification.

Study Startup Responsibilities:

• Supporting study start up activity from point of initial site approach, through to Research Governance Office (RGO) authorisation
• Accurately draft and finalise the following according to site or sponsor timelines:
  • Human Research Ethics Applications (HREA)
  • Site Specific Assessments (SSA)
  • Site specific Informed Consent Forms (ICFs)
  • Inter Department Agreements (IDAs)
• Review study documentation in line with local ethics or governance requirements
• Maintain an up‐to‐date understanding of the legal, ethical, and regulatory frameworks governing clinical research and applying this knowledge to informed decision‐making.
• Provide financial management support related to study start up
• Conduct efficient and accurate study handovers to clinical teams as required.

Clinical Trials Management System (CTMS) Responsibilities:

• Completion of Minimum data set fields as required
• Creation of protocol notes in CTMS to provide current study updates
• Support builds in the Clinical Trials Management System (CTMS) as per local site practices
• Logging of expenditures in CTMS
• Creation of statements of work (SOW) in CTMS

Additional Benefits (where applicable):

Flexible work opportunities, Salary packaging and meal entertainment benefits, accrued days off (ADOs), fitness passport, employee assistance program (EAP)

Child Safe Standards:

SCHN is committed to maintaining a child-safe environment that respects and upholds the rights of children and young people, in line with NSW Health’s commitment to the Child Safe Standards. We aim to ensure that children and young people feel safe, supported, and included in their care. All current and prospective staff are expected to prioritise the safety, welfare, and well‑being of children and young people, actively working to protect them from harm and abuse.

Additional Information:

SCHN is an Equal Opportunity Employer that values diversity, recognising that a diverse workforce strengthens our culture and enhances the care we provide to children, young people and their families. Permanent NSW Health roles require Australian citizenship or permanent residency. Temporary visa holders may be considered where no suitable Australian citizen or permanent resident is identified. NSW Health vaccination and screening requirements must be met prior to commencement. This position requires a Working with Children Check (WWCC) issued by the Office of the Children’s Guardian. Where required, overseas qualifications must be formally assessed by the Department of Education or relevant authority for recognition in Australia. An Eligibility List may be created for future temporary full or part time vacancies.

Aboriginal and Torres Strait Islander people are strongly encouraged to apply. We recognise the value of Aboriginal staff providing health care to Aboriginal children and families. For application support, visit the NSW Health Aboriginal Recruitment tool, Stepping Up to assist in preparing your application, or contact the SCHN’s Aboriginal Workforce Consultant at [e-mail] For technical support please contact 1300 679 367 Learn more about The Sydney Children’s Hospitals Network Facebook, Instagram, LinkedIn and YouTube

• Relevant tertiary qualifications in a relevant field, or equivalent work experience with study start up or clinical trial management in a clinical research environment, or a combination of study and work experience.
• Demonstrated knowledge of legislation and guidelines for conducting clinical trials in Australia and experience in obtaining and maintaining ethics and governance approvals.
• Demonstrated ability to exercise autonomy and initiative in relation to day‑to‑day problem solving, communication and decision making.
• Demonstrated ability to meet clinical trial study start up deadlines considering competing research and priorities including project, time and workload management skills with demonstrated ability to prioritise, have attention to detail, manage multiple tasks, and meet deadlines in a highly paced environment.
• Strong computer skills and willingness to utilise existing and new systems for clinical trials project management and data.
• Ability to work independently and collaboratively and take a consultative approach to ensure delivery of complex tasks to meet pre‑defined time, budget and quality targets.
• Interpersonal, verbal and written communication skills in liaising with a variety of stakeholders/audiences.
• Demonstrate a culture of quality and patient safety in clinical research.