Macquarie Medical Systems jobs

The Opportunity

Cochlear has an opportunity for a 24-month fixed-term contract Clinical Trial Assistant role based in our Macquarie University, Sydney office , operating under a hybrid work model .

In this role, the successful Clinical Trial Assistant will provide administrative support to the Clinical Operations team, assisting Clinical Project Managers and Clinical Research Associates with the coordination and execution of clinical trial activities. The role supports clinical documentation management, trial payments, device tracking, maintenance of clinical trial systems and continuous improvement initiatives to ensure high-quality clinical research delivery .

Responsibilities include:

• Supporting clinical trial payments, purchase orders and supplier budget administration.

• Managing and maintaining electronic Trial Master Files (eTMF) and associated documentation.

• Assisting with Investigational Site File (ISF) creation and maintenance.

• Tracking and collecting essential clinical trial documents from study sites.

• Updating and maintaining the Clinical Trial Management System (CTMS) and related systems.

• Supporting clinical operations teams with study administration, reporting and process improvement initiatives.

What makes this opportunity unique?

This role provides an excellent opportunity to develop hands-on experience in clinical research within a leading medical device organisation. You'll work alongside experienced clinical professionals, gain exposure in clinical trials and contribute to technologies that help people connect through hearing.

About You. As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:

Essential :

• Bachelor’s degree in Health Sciences , Nursing, Biomedical Sciences, Pharmacy, Pharmacology or a related discipline.

• Experience in clinical research, healthcare administration, pharmaceutical or medical device environments.

• Strong organisational and planning skills with the ability to manage multiple priorities.

• Excellent attention to detail and accuracy.

• Proficient computer skills including Microsoft Office and web-based applications.

• Strong written and verbal communication skills.

• Ability to work independently and collaboratively within a team environment.

• Analytical and problem-solving capabilities.

Ideal:

• Knowledge of clinical trial processes and documentation requirements.

• Familiarity with electronic Trial Master Files (eTMF) and Clinical Trial Management Systems (CTMS).

• Understanding of Good Clinical Practice (GCP) and /or ISO14155 requirements.

• Experience supporting project or study administration activities.

• Exposure to quality management or regulated environments.