Ethics and Regulatory Specialist
Nucleus Network | Melbourne or Brisbane | Clinical Research
JOIN OUR TEAM
Nucleus Network is inviting applications for an Ethics and Regulatory Specialist. This role is open to candidates based in either Melbourne or Brisbane.
In this position, you will be responsible for the efficient preparation and coordination of all documentation required to obtain Human Research Ethics Committee (HREC) and Institutional Review Board (IRB) approvals across the lifecycle of clinical trials. You will work closely with internal and external stakeholders to support the successful delivery of our clinical trials.
We are looking for a detail-oriented, collaborative professional who is passionate about supporting high-quality research.
POSITION DETAILS
Role: Ethics and Regulatory Specialist
Company: Nucleus Network
Locations: Melbourne | Brisbane
Department: Clinical Development
Reports to: Associate Director of Clinical Development
Employment Type: Full-time
ROLE OVERVIEW
Clinical trials cannot proceed without ethics approval. Before enrollment begins, before data is collected, ethics committees must review and approve each study.
The Ethics and Regulatory Specialist ensures this process runs smoothly and efficiently.
You will serve as the primary point of contact for ethics matters. You will prepare submission packages, respond to queries, track approvals, and maintain documentation. You will collaborate with sponsors, project managers, recruitment teams, and ethics committees to keep studies moving forward.
Your work directly enables clinical trials to start on time and remain compliant throughout their lifecycle.
KEY RESPONSIBILITIES
Ethics and Regulatory Management
- Serve as the primary ethics contact for Sponsors and Project Managers
- Maintain current knowledge of local regulatory and ethics requirements
- Ensure ongoing compliance with all applicable standards
- Provide guidance on ethics processes, timelines, and documentation requirements
- Identify and escalate risks or issues that may delay approvals
HREC and IRB Submissions
- Independently prepare, review, and coordinate ethics submission and amendment packages
- Ensure submissions align with ICH-GCP, regulations, and internal quality standards
- Manage submissions for initial approvals, amendments, study notifications, and site-level documentation
- Liaise with Sponsors to confirm documentation requirements and timelines
- Coordinate responses to ethics queries, submitting only Sponsor-approved documents
- Work with Project Managers and Recruitment teams on ethics feedback for advertising materials
- Notify Sponsors and Project Managers of ethics approvals and outcomes
- Perform quality review of submission and approval packages as directed
Documentation and Systems
- Ensure start-up and site-level critical documents are accurate, complete, and maintained
- Enter ethics documentation and approvals into systems accurately and on time
- Maintain the Ethics/IRB submission tracker with daily updates
- Provide regular status updates to the Associate Director of Clinical Development
Stakeholder and Vendor Coordination
- Attend ethics, study, and project management meetings as required
- Coordinate assembly and distribution of study materials to internal teams, Sponsors, and vendors
- Liaise with translation vendors when document translation is required
- Work with the Contracts Specialist to confirm financial reimbursement requirements in the PICF
Complaints and Privacy
- Support ethics-related complaints and privacy matters as delegated
- Ensure issues are tracked, managed, and responded to appropriately
REQUIREMENTS
Experience and Knowledge
- Previous experience in ethics submissions, regulatory affairs, or clinical trial start-up
- Understanding of HREC and IRB processes and requirements
- Familiarity with ICH-GCP and applicable regulations
Skills and Competencies
- Strong attention to detail and accuracy
- Excellent written and verbal communication
- Ability to manage multiple submissions and deadlines
- Stakeholder management and relationship-building
- Problem-solving and risk identification
- Proficiency with document management systems and trackers
Personal Attributes
- Detail-oriented and organized
- Collaborative team player
- Comfortable working with sponsors and senior stakeholders
- Passionate about supporting high-quality clinical research
- Able to work independently and take ownership
WHAT THE ROLE ENTAILS
Typical Activities
- Preparing ethics submission packages for new studies
- Responding to HREC queries on active submissions
- Updating ethics trackers with recent approvals
- Meeting with Sponsors to confirm documentation requirements
- Liaising with Project Managers on advertising materials
- Reviewing submission packages for quality and completeness
- Coordinating with translation vendors
- Providing status updates to leadership
- Attending project management meetings
Key Stakeholders
- Sponsors
- Project Managers
- HREC and IRB committees
- Recruitment teams
- Contracts Specialists
- Translation vendors
- Internal study teams
WHY JOIN NUCLEUS NETWORK
High-Performing Team
Join a collaborative team where quality, pace, and impact matter. You will work alongside professionals committed to excellence.
True Ownership
This role offers real responsibility. You will own ethics submissions from start to finish and see the direct impact of your work.
Stakeholder Exposure
Work closely with Sponsors, Project Managers, and senior stakeholders. Build relationships that matter for your career.
Critical Function
Ethics approval is the gateway to every clinical trial. Your work enables studies to proceed and patients to be enrolled.
Career Development
Nucleus Network supports professional growth. You will have opportunities to develop skills and advance your career.
Purpose-Driven Work
Contribute to clinical research that advances medicine and improves patient outcomes.
LOCATIONS
This role is available in two locations:
Melbourne
Candidates based in Melbourne are welcome to apply.
Brisbane
Candidates based in Brisbane are welcome to apply.
Please indicate your preferred location in your application.
APPLICATION PROCESS
Step 1: Submit your application through the Nucleus Network careers portal
Step 2: Hiring team reviews all submissions
Step 3: Qualified candidates contacted for initial conversation
Step 4: Interviews with Clinical Development leadership
Step 5: Decision and offer communicated
TO APPLY
Please submit:
- Your resume highlighting relevant experience
- Brief note on your ethics or regulatory background
- Your preferred location (Melbourne or Brisbane)
- Why you are interested in joining Nucleus Network
Apply for the Ethics and Regulatory Specialist position at Nucleus Network.
Nucleus Network is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified candidates. If you need accommodations during the application process, please let us know.
