Employment Type:Temporary Full Time up until 7 September ****
Position Classification:Health Mgr Lvl 1
Remuneration:************** full-time equivalent base salary range (+12% super + 17.5% leave loading and salary packaging)
Hours Per Week:38
Location:Network
Applications Close:Midnight on 9 August ****
For role related queries or questions contact:Natasha Edirisinghege on ******
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 Centres (CRC), 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 aims to translate new evidence into clinical care and treatment at both sites.
The Role
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, skilled 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
Supporting and completing ongoing study amendments
Supporting feasibility assessments where required
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)
Requirements
Aresume(maximum 5 pages) outlining your experience
Responses to the questions below:
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.
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.
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 ******
For technical support please contact ************
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