Impactful Clinical Study Coordinator

Proclinical; Sydney; On-site; AUD 70,000 - 110,000; Full time

Job summary

Proclinical is seeking a Clinical Study Coordinator to support the coordination of clinical studies and related trial activities while ensuring compliance with regulatory requirements and company policies. You will facilitate collaboration between sponsors, CROs, and study teams to meet project goals effectively.

The role covers coordination from start-up to close-out, organizing study meetings, ensuring ICH GCP compliance, supporting ethics submissions, managing budgets, and maintaining study

Qualifications

• Bachelor-level life sciences degree or higher.
• Knowledge of ICH GCP principles and clinical trial processes.
• Experience coordinating clinical studies and CRO/sponsor interactions.

Responsibilities

• Coordinate clinical trial activities from start-up to close-out.
• Organize and lead study meetings (Kick-Off, Risk Meetings) with senior staff.
• Ensure compliance with ICH GCP, SOPs, and local regulatory requirements.
• Support ethics submissions and HREC processes as needed.
• Identify and report quality issues; collaborate with Quality team to resolve them.
• Manage study expenses and ensure accurate billing per CTAs/CTRA.
• Maintain study documentation and databases; ensure timely data entry and e-CRF completion.
• Assist with site audits and responses to audit findings.

Skills

Organizational skills

Stakeholder communication

Flexibility

Attention to detail

MS Office

ICH GCP knowledge

Clinical research coordination

ECG + vital signs (optional)

Basic CPR

Education

Science degree (biochemistry / molecular biology / medical science)

Tools

e-CRF systems

CTMS

Job description

Proclinical is seeking a Clinical Study Coordinator to support the coordination of clinical studies and related trial activities while ensuring compliance with regulatory requirements and company policies. You will facilitate collaboration between sponsors, CROs, and study teams to meet project goals effectively.

The role covers coordination from start-up to close-out, organizing study meetings, ensuring ICH GCP compliance, supporting ethics submissions, managing budgets, and maintaining study