Clinical Research Associate

Role overview

This position is for a Clinical Research Associate based in Sydney, New South Wales, Australia. The role focuses on supporting the end-to-end management of clinical trials and studies, with strong attention to compliance, documentation, and coordination across sites and investigators.

Key responsibilities

• Manage and coordinate all stages of clinical studies, ensuring the trial runs smoothly from start to finish.
• Prepare study protocols and supporting documents needed for ethics committee review, and work to secure approval within the required timeline.
• Oversee trial conduct and site coordination while strictly following GCP principles and internal SOPs.
• Contribute to query handling, site closure activities, and collection of documents needed for the final clinical study report after the trial concludes.
• Keep EDC and CTMS records current, complete, and accurate in line with study requirements.
• Ensure serious adverse events and adverse drug reactions are reported and followed up promptly according to the relevant internal procedures.
• Maintain investigator files and trial master files with proper updates.
• Develop and preserve strong working relationships with investigators and study sites.
• Complete site visit reports and related correspondence within required timelines.

Qualifications and experience

• A bachelor’s degree in biomedical sciences, a science-related discipline, or an equivalent qualification such as BSc, Registered Nurse, or BPharm.
• For senior-level consideration, 3 to 10 years of clinical operations or monitoring experience is expected.
• Strong spoken and written English skills are required.
• Good communication and organizational ability are important.
• A proactive and responsible work style is preferred.

About the organization

The employer is a contract research organization working in pharmaceutical R&D and clinical studies. It provides end-to-end support for clinical development, including chemical and biological drugs as well as vaccines. Established in 2004, the company has delivered technical services to clients across more than 20 major therapeutic areas and operates through offices in multiple provinces and cities in China. Its operating model is built around detailed SOPs and international standards such as ICH-GCP, with established collaboration across a large network of study sites.

Additional information

This is a full-time onsite role in Sydney. No compensation details, vacancy count, joining date, or application deadline were provided.