Contract Clinical Research Associate

0.4 FTE

Melbourne, Australia

Join a global clinical research organization dedicated to advancing cutting-edge therapies and improving patient outcomes. We are seeking an experienced Contract Clinical Research Associate (CRA) to support the successful delivery of clinical trials across Australia.

This is a remote, part-time opportunity (0.4 FTE) offering flexibility while working closely with investigative sites and cross-functional study teams.

Key Responsibilities

- Conduct site qualification, initiation, monitoring, and close-out visits.
- Assess and identify suitable investigative sites and support site selection activities.
- Train site personnel on study protocols, regulatory requirements, and study procedures.
- Ensure sites remain compliant with GCP, local regulations, sponsor requirements, and study protocols.
- Perform source data verification and review clinical documentation for accuracy, completeness, and consistency.
- Monitor investigational product accountability, storage, dispensing, and reconciliation.
- Support submissions to Ethics Committees and Regulatory Authorities, as required.
- Manage site communications, action items, and issue resolution throughout the study lifecycle.
- Review and maintain essential study documentation within the Trial Master File (TMF).
- Facilitate data query resolution and ensure timely reporting of study activities.
- Build and maintain strong relationships with investigators,



study coordinators, and internal stakeholders.
- Participate in study team meetings and contribute to project success.

Skills & Qualifications

- Strong knowledge of clinical trial processes, ICH-GCP guidelines, and applicable regulatory requirements.
- Excellent written and verbal communication skills.
- Strong organisational, time management, and problem-solving abilities.
- Ability to effectively manage multiple priorities and deadlines.
- Proficient in clinical trial systems and Microsoft Office applications.
- Strong interpersonal skills and the ability to work collaboratively within global teams.
- Commitment to quality, accuracy, and patient safety.
- Ability to travel up to 75% as required.
- Valid driver's licence.

Experience & Education

- Bachelor's degree in Life Sciences, Nursing, or a related field, or an equivalent combination of education and relevant experience.
- Successful completion of a recognised CRA training programme.
- Minimum of 3 years' clinical research experience, including experience as a Clinical Trial Associate, Study Coordinator, Clinical Research Associate, or similar role.
- Oncology therapeutic experience is preferred.
- Experience independently conducting site monitoring visits across all phases of a clinical trial.
- Strong understanding of site management, protocol compliance, patient safety, and data quality requirements.

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📌 Contract Clinical Research Associate (Sydney)
🏢 Linical-3
📍 Sydney