Company Overview

Wellumio is a venture-backed medical device company on a mission to empower timely stroke intervention with rapid, point-of-care diagnostics.

Magnetic resonance imaging provides valuable information in acute stroke assessment. Yet access is constrained by high costs, infrastructure requirements, and the need to move patients to fixed scanners. Instead of bringing patients to the scanner, Wellumio is developing technology that brings the scanner to the patient.

Wellumio’s MRI-based brain imaging system, Axana®, is a portable, energy-efficient scanner designed for point-of-care use, with an initial focus on acute stroke. Wellumio aims to improve access to brain imaging and support timely diagnosis and treatment.

At Wellumio you will:

- Work closely with colleagues across clinical research, medicine, engineering and commercial disciplines.

- Support the clinical research and documentation needed to advance a novel brain imaging technology.

- Contribute to a growing team that values initiative, attention to detail, clear communication, and collaboration.

Position Overview:

The Clinical Research and Ethics Coordinator will work closely with the Head of Global Clinical & Regulatory Affairs to coordinate ethics and research governance documentation across three to four Australian clinical study sites. The role requires an experienced research administrator who can progress agreed tasks reliably, maintain accurate records, and work within established priorities and review processes.

Support timely ethics and research governance submissions by:

- Preparing and coordinating ethics and research governance applications, amendments, and progress reports through Ethics Review Manager (ERM), for review and approval before submission.

- Tracking submission requirements, correspondence, approvals, and deadlines.

Maintain accurate and accessible clinical and regulatory records by:

- Organising study files, approval records, agreements, and essential documents.





- Maintaining document registers and version control and following up missing information.

Support coordination with study sites and collaborators by:

- Arranging meetings and training sessions, recording actions, and following up outstanding items.

- Preparing routine correspondence and coordinating document collection and signatures.

Help the clinical programme stay organised by:

- Maintaining action trackers and providing concise updates on progress and outstanding tasks.

- Flagging approaching deadlines, missing documents, and delays to the Head of Global Clinical & Regulatory Affairs.

The position is initially part-time at 0.4 FTE, with priorities agreed with the Head of Global Clinical & Regulatory Affairs to match the available hours. Hours and responsibilities may develop as Wellumio’s clinical programme grows.

What You’ll Do:

Key responsibilities include:

- Coordinate the preparation, review, and submission of ethics and research governance documentation through ERM across participating Australian sites, under the direction of the Head of Global Clinical & Regulatory Affairs.

- Collect and check supporting documents for study start-up, including investigator CVs, training records, signatures, and site documentation.

- Maintain clinical and regulatory files, document registers, version histories, and approval records.

- Format, proofread, and check the consistency of study documents before review and submission.

- Track submission deadlines, approval conditions, and outstanding actions, escalating delays or missing information.

- Liaise with hospital research offices, investigators,



study teams, and external partners to obtain documents and follow up agreed actions.

- Coordinate meetings and study training sessions, maintain attendance records, and prepare minutes and action lists.

- Assist with the administrative preparation and tracking of study agreements, budgets, and invoices.

- Help prepare documentation for monitoring visits, audits, and regulatory submissions.

- Follow Wellumio’s procedures and applicable research requirements, maintaining confidentiality and handling sensitive information appropriately.

What You’ll Bring:

- Demonstrated experience preparing and coordinating Australian human research ethics and site governance submissions.

- Practical experience using Ethics Review Manager (ERM) to manage applications, amendments, supporting documents, and correspondence.

- Strong organisational skills, attention to detail, and the ability to manage agreed priorities within part-time hours.

- Clear written and verbal communication skills, with confidence following up outstanding information professionally.

- Proficiency in Microsoft Word, Excel, Outlook, and shared document systems.

- An understanding of Good Clinical Practice and the importance of accurate, traceable research records.

- Ability to work independently on agreed tasks, follow established review and approval processes, and seek guidance when issues require decisions beyond the agreed scope.

Typical qualification is a bachelor’s degree in life sciences, health sciences, a related discipline, or equivalent relevant qualified experience. Demonstrated experience coordinating Australian research ethics and governance submissions is essential.

How to Apply

Join Wellumio and support the clinical research behind a novel portable brain imaging technology.

Please submit your CV and a brief cover letter outlining your relevant experience, availability, and interest in the role.

📌 Clinical Research and Ethics Coordinator (Clayton)
🏢 Wellumio
📍 Clayton