Remote job · Business and finance
Regulatory and Site Start Up Specialist
In one line: Regulatory and Site Start Up Specialist is a remote role in Australia at a clinical research organisation.
- Remote (Australia)
- A clinical research organisation
- Posted 7 Oct 2026
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https://keywordise.com/mcpApply to Keywordise job tutahy43zzAbout the role
Handle regulatory and site start-up work for clinical trials, from submissions to authorities and ethics committees to site activation readiness. The role supports study teams and sites so trials can begin on time and in line with regulations.
At a glance
- PayNot stated in the posting
- Remote scopeRemote, Australia
- Posted7 Oct 2026
- Last checked19 Oct 2026
What you will do
- Ensure sites are ready to activate on schedule and in good quality, anticipating and reducing risks
- Prepare trial application forms and submission dossiers for authorities, ethics committees and local bodies
- Liaise with authorities and ethics committees and manage their responses
- Report submission progress to start-up and regulatory leads and to project teams
- Keep project plans, trackers and regulatory intelligence tools current
- Collect and review essential documents and customise patient information and consent forms
What they look for
- Proven experience in regulatory and site start-up activities for clinical trials
- Knowledge of ICH-GCP and local and international trial regulations
- Ability to prepare submissions within required timelines and obtain approvals
- Skill in coordinating translations and managing document collection
- Strong communication with cross-functional teams such as feasibility, clinical operations and contracts
Questions about this job
Is this job fully remote, and from where?
Yes. The posting lists Regulatory and Site Start Up Specialist as a remote role for candidates in Australia.
What does this job pay?
The posting does not state a salary, so there is no figure to quote.
What experience is needed?
The posting asks for: proven experience in regulatory and site start-up activities for clinical trials; knowledge of ICH-GCP and local and international trial regulations; ability to prepare submissions within required timelines and obtain approvals.
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