Company Description Mobius Medical is a boutique, full-service clinical research partner operating across the United States, Australia, and New Zealand with a globally distributed team. The organization is supported by an ISO:9001-certified Quality Management System and comprehensive standard operating procedures.

Mobius

Medical has extensive regulatory experience across multiple jurisdictions and all phases of therapeutic goods’ clinical development, with a particular focus on early phase clinical research and global site activation. The company manages clinical trials from strategic design through clinical report production and offers specialized services such as monitoring, biostatistical design and analysis, and in-house built Electronic Data Capture (EDC) solutions. All data solutions comply with global regulatory requirements, and Mobius Medical can also act as a local legal sponsor for clinical trials in Australia.

Role Description The Clinical Research Associate II role is a full-time, on-site position based in the Greater Melbourne Area. This role is responsible for monitoring clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.

Day-to-day activities include conducting site qualification, initiation, routine monitoring, and close-out visits, as well as verifying source data, reviewing case report forms, and ensuring accurate and timely data entry.

The Clinical Research

Associate II collaborates with project managers, investigators, and site staff to support study start-up, manage site communications,



and resolve operational issues. The role also involves preparing monitoring reports, maintaining essential documents, contributing to risk assessments, and supporting continuous improvement of clinical operations processes.

Qualifications

- Candidates should possess robust expertise in clinical trial protocols, including interpretation, implementation, and adherence at investigative sites.
- Candidates should possess practical experience as Clinical Research Associates, including on-site monitoring and remote oversight of clinical studies.
- Candidates should possess solid knowledge of clinical trials and clinical research, including GCP, ICH guidelines, and relevant local regulatory requirements.
- Candidates should possess skills in clinical operations, including site management, documentation control, and coordination of trial activities.
- Bachelor’s degree or higher in life sciences, nursing, pharmacy, or a related field.
- Previous experience in a CRA role (typically 2–4 years) within a CRO, sponsor, or equivalent clinical environment.
- Strong analytical, organizational, and time-management abilities, with attention to detail and quality standards.
- Effective written and verbal communication skills, with the ability to build collaborative relationships with site staff and internal teams.
- Proficiency with electronic data capture systems and common office software; familiarity with ISO-certified quality systems is an advantage.
- Ability to travel to clinical sites within the Greater Melbourne Area and occasionally interstate, as required.

📌 Clinical Research Associate II (Melbourne)
🏢 Mobius Medical
📍 Melbourne