Clinical Research Associate

Company overview

Mobius Medical is a specialist contract research organisation with a lean, full-service model and teams working across the United States, Australia, and New Zealand. The company focuses on medical device clinical trials and is backed by an ISO 9001-certified quality management system, which supports its standard operating procedures and quality framework. It brings substantial regulatory know-how across multiple regions and across the full development lifecycle for therapeutic goods, with especially strong capability in early-stage studies. Its services cover end-to-end clinical trial delivery, from trial strategy and study design through to clinical reporting.

Role summary

This is a full-time Clinical Research Associate position based in North Sydney, NSW, with a hybrid setup that combines on-site work and some flexibility to work from home. The role is part of the company’s growth and is focused on ensuring clinical studies are conducted in line with study protocols, Good Clinical Practice (GCP), and all relevant regulatory obligations.

Key duties

• Carry out site initiation, routine monitoring, and close-out activities at clinical trial locations.
• Check source data against study records and maintain accurate essential trial documentation.
• Track and resolve data queries promptly to keep study data complete and reliable.
• Work closely with investigators, site teams, and internal clinical operations colleagues to support recruitment and overall site performance.
• Identify and manage risks that could affect study timelines, quality, or compliance.
• Review protocols and study-related documents, and provide support for ethics submissions when required.
• Contribute to ongoing improvements in operational processes and study execution.

Requirements

• At least 1 year of site monitoring experience, ideally gained as part of a CRA team or in a similar clinical research role.
• A bachelor’s degree or higher in life sciences, pharmacy, nursing, or another relevant scientific or health-related field.
• Working knowledge of ICH-GCP, local and international regulatory expectations, and ethics committee processes.
• Strong organisational ability, documentation accuracy, time management, and attention to detail, with a clear focus on data integrity.
• Well-developed written and spoken communication skills, with the ability to build effective working relationships.
• Confidence using electronic data capture platforms and Microsoft Office tools; experience with EDC in multi-centre studies is an advantage.
• Willingness and ability to travel to Australian sites as needed, with no fixed target for on-site days.
• Applicants must already have the right to work in Australia and must not need visa sponsorship.
• Experience in medical device clinical trials will be considered a strong plus.

Additional information

This position is offered on a full-time basis. The work arrangement is hybrid, meaning it includes both on-site responsibilities and work-from-home flexibility. The role is located in North Sydney, NSW, Australia.

Notes

No salary or stipend information was provided. No number of vacancies, start date, or application deadline was specified.