Do you thrive in a collaborative clinical research environment where you can lead study activities and contribute to the successful delivery of impactful clinical trials?

Proclinical is seeking a Clinical Study Coordinator to manage clinical studies and related trial activities. This role involves ensuring high standards of scientific and clinical methodology, compliance with ICH-GCP guidelines, and adherence to local regulatory requirements. You will play a key role in fostering collaboration between study teams, sponsors, and CROs while mentoring and training junior team members.

Responsibilities

- Oversee clinical trial activities from start-up to close-out, ensuring adherence to protocols and SOPs.
- Coordinate and lead study-related meetings, including Study Kick-Off and Risk Meetings.
- Ensure compliance with ICH-GCP, NHMRC guidelines, and other regulatory requirements.
- Manage Human Research Ethics Committee (HREC) processes and assist with ethics submissions as needed.
- Accurately track and manage study expenses and communicate protocol amendments.
- Organize and deliver training for study team members and the Clinical Operations team.
- Proactively identify and resolve study management issues, escalating as necessary.
- Conduct routine clinical procedures such as vitals, ECGs, and blood collection within scope of practice.




- Ensure timely follow-up on medical assessments and participant safety.
- Maintain accurate and up-to-date study documentation and databases.
- Participate in site audits, prepare responses to findings, and implement corrective actions.
- Mentor and train new team members, fostering a culture of quality and compliance.
- Contribute to the development and improvement of SOPs and operational processes.
- Pursue ongoing professional development and maintain training records.
- Comply with occupational health and safety regulations.

Key Skills & Requirements

- Strong knowledge of ICH-GCP, NHMRC, and applicable regulatory requirements.
- Proficiency in MS Office and clinical data systems.
- Experience in clinical assessment techniques (e.g., vital signs, ECG, venepuncture) preferred.
- Excellent planning, organizational, and time management skills.
- Robust interpersonal and communication skills, with the ability to liaise across teams and stakeholders.
- Demonstrated ability to work independently and as part of a team.
- Commitment to quality, continuous learning, and improvement.
- Flexibility to adapt to changing work environments and timelines.
- Tertiary qualification in health, social, or biological sciences.
- Experience in clinical research coordination or project management, preferably in early-phase trials.

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📌 Clinical Study Coordinator (City of Sydney)
🏢 Proclinical Staffing
📍 City of Sydney