Clinical Trials Start-Up Specialist

NSW Health; Sydney; On-site; AUD 91,000 - 121,000; Full time

Benefits offered by this job

Flexible work opportunities

Salary packaging

Meal entertainment benefits

Accrued days off (ADOs)

Fitness passport

Employee assistance program (EAP)

Job summary

NSW Health’s Clinical Trials Start-Up Officer role supports and completes ongoing study amendments and feasibility assessments. The position works across CHW and SCH sites, assisting CRCs with start-up activities and administrative functions while building professional relationships with sponsors, investigators, and supporting departments.

Key duties include drafting HREAs, SSAs, ICFs, and IDAs, reviewing study documentation for ethics and governance, managing CTMS data, and providing financial

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
• Supporting study start up activity from point of initial site approach, through to Research Governance Office (RGO) authorisation
• Accurately draft HREA
• Accurately draft SSA
• Accurately draft ICFs
• Accurately draft 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
• 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)

Job description

NSW Health’s Clinical Trials Start-Up Officer role supports and completes ongoing study amendments and feasibility assessments. The position works across CHW and SCH sites, assisting CRCs with start-up activities and administrative functions while building professional relationships with sponsors, investigators, and supporting departments.

Key duties include drafting HREAs, SSAs, ICFs, and IDAs, reviewing study documentation for ethics and governance, managing CTMS data, and providing financial