Clinical Research, Study Start Up Specialist

Health and Aged Care Professionals – Research VIC

$80,000 - $90,000 a year

Full time

3d ago , from Health and Aged Care Professionals

- Attractive salary package with salary packaging benefits.
- Take ownership of ethics, governance, and clinical trial start-up activities.
- Work across a growing portfolio of sponsored clinical research studies.
- Highly autonomous role within a collaborative and expanding specialised research team.

Benefits

- Attractive salary package with salary packaging benefits.
- Take ownership of ethics, governance, and clinical trial start-up activities.
- Work across a growing portfolio of sponsored clinical research studies.
- Highly autonomous role within a collaborative and expanding specialised research team.

About the Company
Join a growing Australian clinical research organisation supporting the delivery of sponsored clinical trials in partnership with pharmaceutical, biotechnology, and research organisations.
With an increasing portfolio of clinical studies, the organisation provides a team-oriented environment where experienced research professionals can take ownership of study start-up and contribute to the continued development of clinical research capability.

About the Opportunity
An prospect exists for a Clinical Research Start-Up Specialist to coordinate clinical trial activation, with a particular focus on ethics, governance, and regulatory submissions. You will manage activities across the start-up lifecycle, working closely with sponsors, CROs, investigators, research teams, and governance stakeholders to progress studies efficiently towards activation. The position offers considerable autonomy and would suit someone with established HREC and research governance experience who is confident managing multiple submissions, navigating approval requirements, and driving study start-up timelines.

Duties





- Coordinate ethics and governance activities across new and existing clinical trials.
- Prepare, review, and manage HREC submissions and associated research documentation.
- Coordinate site governance applications, regulatory requirements, and study amendments.
- Respond to queries from ethics committees, governance offices, sponsors, and other stakeholders.
- Manage study start-up timelines and ensure approval milestones progress efficiently.
- Coordinate documentation required to move studies from initial start-up through to site activation.
- Work closely with sponsors, CROs, investigators, and internal research teams throughout the approval process.
- Support clinical trial agreements, budgets, feasibility, and other start-up activities as required.

Skills and Experience

- Previous experience working with HREC and research governance processes is essential.
- Demonstrated experience preparing, coordinating, or reviewing human research ethics applications.
- Experience within clinical trial start-up, research governance, clinical research administration, or a related environment.
- Good understanding of Australian clinical research ethics and governance requirements.
- Exposure to site-specific assessments, CTN processes, study amendments, or regulatory documentation is highly regarded.
- Strong organisational skills with the ability to independently manage multiple submissions and deadlines.
- Excellent written communication and confidence engaging with researchers, sponsors, CROs, and governance stakeholders.
- Tertiary qualification in Health, Life Sciences, or a related discipline.

Culture
Join a growing and collaborative research environment where people are encouraged to take ownership, contribute ideas, and improve how studies are delivered. The team values quality, agility, and practical problem-solving, offering experienced professionals the autonomy to manage their work while collaborating closely across clinical operations.

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📌 Clinical Research, Study Start Up Specialist (Melbourne)
🏢 Health and Aged Care Professionals
📍 Melbourne