Clinical Research Associate (Clinical Research)

Location: Melbourne, Australia; flexible hybrid work with offices in Melbourne and Sydney.

Company

Clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Conduct site selection, initiation, monitoring, and close-out visits according to study protocols, GCP, ICH guidelines, and regulatory requirements.
• Manage site recruitment plans, study training, communications, and ongoing project expectations.
• Evaluate site quality and protocol compliance, escalate issues, and support corrective action plans.
• Track regulatory submissions, approvals, recruitment, enrollment, CRF completion, and data query resolution.
• Maintain TMF and verify that Investigator Site Files are kept according to GCP and local requirements.
• Prepare monitoring reports, follow-up letters, site documentation, and other study records while collaborating with study teams.

Requirements

• Bachelor’s degree in a scientific or healthcare discipline, or an equivalent combination of education, training, and experience.
• At least 9 months of independent on-site monitoring experience.
• Knowledge of clinical research regulations, including GCP and ICH guidelines.
• Therapeutic and protocol knowledge gained through company training.
• Proficiency with Microsoft Word, Excel, PowerPoint, laptop computers, and applicable mobile devices.
• Strong organizational, problem-solving, time management, financial management, and relationship-building skills.

Culture & Benefits

• Flexible hybrid work environment.
• Competitive salary with car and health allowances.
• Career growth opportunities across FSO and FSP models.
• Opportunity to work with experienced managers across multi-phase clinical trials.
• Visa sponsorship is available for candidates who meet the requirements and eligibility criteria.