Clinical Research Associate: Monitor Trials & Compliance …, City of Sydney

The Clinical Research Associate is responsible for managing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, ICH-GCP, and applicable regulations. This includes site selection, initiation, monitoring, and close-out activities, while ensuring data quality and patient safety. The role reports to the Clinical Project Manager.

Key Responsibilities

Identify, assess, and initiate investigational sites

Conduct feasibility, pre-study, initiation, monitoring, and close-out visits

Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements

Perform source data verification and ensure data accuracy and completeness

Monitor patient recruitment and support sites in meeting targets

Ensure proper reporting of adverse events and protocol deviations

Manage investigational product handling, storage, and accountability

Maintain study documentation (TMF/eTMF, Investigator Files)

Write monitoring reports and follow-up communications

Collaborate with project teams, sponsors, and site staff

Support audits/inspections and mentor junior CRAs

Requirements

Degree in a scientific field

Minimum 2 years’ CRA or clinical trial monitoring experience

Robust knowledge of ICH-GCP, ISO14155, and clinical trial processes

Good English and Microsoft Office skills

Robust organizational, communication, and problem-solving abilities

Ability to work independently and in a team

What we offer

We offer a market-competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.

J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3r46pq