Clinical Trials Start-Up Specialist (Temp)

The Sydney Children's Hospitals Network; 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

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Autonomy & initiative

Problem solving

Time & workload management

Attention to detail

Interpersonal communication

Written communication

Strong computer skills

Independent & collaborative work

Education

Relevant tertiary qualifications or equivalent

Job description

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.