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

Ready to be the heartbeat of clinical research? Join our client as a Study Coordinator and assist in turning innovative science into life-changing care!

Proclinical is seeking a Clinical Study Coordinator to support the coordination of clinical studies and related trial activities. This role involves ensuring compliance with scientific and clinical methodologies, regulatory requirements, and company policies. You will play a key role in facilitating collaboration between sponsors, Contract Research Organizations (CROs), and study teams to meet project goals effectively.

Responsibilities:

• Coordinate clinical trial activities from start-up to close-out, ensuring adherence to protocols and SOPs.
• Organize and lead study-related meetings, such as Study Kick-Off and Risk Meetings, with senior staff support.
• Ensure compliance with ICH GCP, company SOPs, and local regulatory requirements.
• Support the Human Research Ethics Committee (HREC) process and assist with ethics submissions when required.
• Identify and report quality issues, collaborating with the Quality team to resolve them.
• Manage study expenses, ensuring accurate and timely billing per Clinical Trial Research Agreements (CTRA).
• Organize and deliver study-related training for team members.
• Conduct routine clinical procedures during screening, such as vitals, ECGs, and blood collection, within the scope of practice.
• Ensure participant safety through timely follow-ups on medical assessments and escalation of anomalies.
• Contribute to continuous improvement by assisting in the development and review of SOPs.
• Participate in site audits and assist with responses to audit findings.
• Maintain accurate and up-to-date study documentation and databases.
• Ensure timely data entry, e-CRF completion, and query resolution.
• Pursue ongoing professional development and maintain current training records.
• Comply with all occupational health and safety regulations and policies.

Key Skills and Requirements:

• Strong organizational and interpersonal skills with the ability to communicate effectively with stakeholders.
• Flexibility and adaptability to changing work environments and schedules, including early mornings, evenings, or weekends as needed.
• Commitment to quality, attention to detail, and continuous learning.
• Proficiency in MS Office applications.
• Knowledge of ICH GCP principles.
• Experience in clinical research study coordination.
• Preferred but not essential: experience in clinical assessment techniques such as vital signs, ECG, and blood collection.
• Willingness to acquire additional clinical skills, such as performing 12-lead ECGs, vital signs, and basic CPR.
• A tertiary qualification in science, preferably in biochemistry, molecular biology, medical science, or related life sciences.