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About the Role
Key Health Medical Centre is seeking a highly organised and motivated Clinical Trial Coordinator to join our growing Clinical Research Unit (CRU). This role involves coordinating the day-to-day delivery of multiple clinical trials, ensuring they are conducted safely, ethically, and in accordance with protocols and regulatory requirements. You will work closely with various stakeholders to manage participant coordination, study administration, regulatory compliance, and site operations.
Responsibilities
- Coordinate day-to-day activities across multiple clinical trials
- Support study start-up activities, including site initiation and essential documentation
- Schedule participant visits and coordinate investigator and research nurse availability
- Maintain accurate and audit-ready Trial Master Files (TMF/eTMF) and study documentation
- Assist with monitoring visits, audits, and regulatory inspections
- Support participant recruitment, screening, and enrolment activities
- Coordinate participant appointments within protocol timeframes
- Track participant progress, eligibility, and retention throughout each study
- Assist with ethics submissions, amendments, continuing reviews, and safety reporting
- Maintain regulatory files, delegation logs, and staff training records
- Enter and maintain accurate study data within Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS)
- Ensure studies comply with ICH-GCP, TGA, HREC, and sponsor requirements
- Liaise with sponsors, Clinical Research Associates (CRAs), and CRO representatives
- Work collaboratively with Research Nurses, GPs, and the Clinical Trial Manager
- Assist with study administration, invoicing, ordering study supplies, and maintaining accountability logs
Requirements
- A degree in Health Science, Life Science, Nursing, or a related discipline
- Previous experience as a Clinical Trial Coordinator, Clinical Trial Administrator, Research Nurse, or similar role is highly regarded
- Sound understanding of, or willingness to learn, ICH-GCP and clinical trial regulations
- Excellent organisational and time management skills
- Strong attention to detail and documentation accuracy
- Excellent communication and interpersonal skills
- Confidence working with participants, clinicians, sponsors, and research partners
- Strong computer skills, including Microsoft Office and the ability to learn CTMS, EDC, and eTMF systems
Skills
- ICH-GCP
- GCP Certification
- TGA
- HREC
- Microsoft Office
- CTMS
- EDC
- eTMF
Location
- Sydney CBD South
Work Type
- Full-time
Experience Level
- Previous experience as a Clinical Trial Coordinator, Clinical Trial Administrator, Research Nurse, or similar role is highly regarded
Education Level
- Degree in Health Science, Life Science, Nursing, or a related discipline
Benefits
- Opportunities for ongoing learning and professional development
About the Company
- Key Health Medical Centre is seeking a highly organised and motivated Clinical Trial Coordinator to join our growing Clinical Research Unit (CRU) based in Sydney CBD South.
- This is an exciting opportunity to work alongside experienced Research Nurses, Principal Investigators, and sponsors to help deliver high-quality clinical trials that contribute to improving patient care and advancing medical research.
- Be part of a growing Clinical Research Unit delivering meaningful medical research
- Work alongside experienced clinicians and research professionals
- Gain exposure to a diverse range of clinical trials
- Supportive and collaborative team culture
- Modern CBD South location