Contract Clinical Research Associate

Contract Clinical Research Associate

0.4 FTE

Melbourne, Australia

Join a global clinical research organization dedicated to advancing innovative 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.