Clinical Trial Coordinator

About the organisation

JM Clinical is a purpose-built clinical trial site in Woolloongabba, Brisbane. In a little over a year, the team has established a strong reputation for careful, participant-focused trial delivery and has developed a healthy portfolio of industry-sponsored studies.

The workplace is small, close-knit, and collaborative, with support from the entrepreneurial environment of its biotech sister company, Novoviah. The culture is intentionally protected, and team members are valued, supported, and encouraged to enjoy their work.

Role overview

This newly created position offers an opportunity to step in at an early stage of JM Clinical's growth and take ownership of trial coordination. The role can be structured either part time or full time at the Woolloongabba site.

Until now, coordination duties have been shared across nurses and operations staff alongside their clinical responsibilities. With a solid foundation already in place, including established processes and an operating CTMS (CRIO), this role is designed for someone who can refine the function, strengthen it further, and grow with the business.

The right person will be independent, highly organised, and comfortable working in a small organisation where responsibilities can evolve. A strong focus on participant safety and research quality is essential, along with the initiative to identify priorities without needing constant direction.

Trial management and coordination

• Oversee the day-to-day running of active clinical trials from study start-up through close-out, making sure tasks are completed accurately, within deadlines, and in line with protocol requirements.
• Organise site initiation visits, investigator meetings, monitoring visits, and close-out visits, including preparation of records, samples, and site spaces.
• Keep participant visit schedules on track by coordinating appointments, treatment windows, tests, and follow-up visits.
• Serve as the main site contact for participant communication after the first on-site visit, including reminders, study instructions, and retention support.
• Assist with participant recruitment, screening, and enrolment alongside clinical and recruitment team members.
• Work closely with sponsors, CROs, and study monitors on daily coordination and logistics.

Regulatory and compliance duties

• Review protocols, identify site-level risks, and escalate safety concerns and deviation decisions to the Clinical Trials Manager and Principal Investigator.
• Coordinate safety and regulatory reporting, including adverse event summaries, protocol deviation forms, and monitoring follow-up actions for PI review and approval.
• Ensure trial activities align with ICH-GCP E6(R2), HREC approval requirements, applicable regulations, and site SOPs.
• Contribute to audit readiness and take part in internal or external inspections when needed.
• Maintain working knowledge of Australian TGA requirements relevant to clinical trials.

Documentation and data management

• Keep the Investigator Site File complete and inspection-ready, including essential documents, version control, delegation logs, screening and enrolment trackers, and visit records.
• Create and maintain paper source documents and eSource templates in CRIO, ensuring they are protocol-specific, version controlled, and ready for audit.
• Take responsibility for data entry, reconciliation, and query resolution in sponsor or CRO EDC systems, with a focus on data accuracy and timely CRF completion.
• Manage monitor and CRO data queries within agreed timeframes.
• Maintain site performance records for visit compliance, sample tracking, data entry turnaround, and monitoring findings.

Team and site operations

• Coordinate vendors and equipment readiness, especially for sample workflows, and ensure the site is prepared for upcoming visits and studies.
• Support investigators with appointment coordination, participant flow accuracy, and documentation quality.
• As the team expands, provide support to Clinical Trial Assistants through task oversight and follow-up on progress.
• Contribute to process improvement initiatives and SOP development.

Experience and capabilities

Applicants should bring 3 to 5 years of site-level clinical trial coordination experience, with sponsor-side or CRO experience also considered if directly comparable. A sound understanding of ICH-GCP principles and Australian clinical trial regulations is required, along with experience managing ISFs, EDC platforms, and CRF completion.

Strong general IT ability is important, including confidence using CTMS platforms, Microsoft Office, and electronic data systems. Experience supporting monitoring visits and working with sponsor and CRO teams is also expected. The role suits someone with excellent organisation, the ability to manage several trials at once, strong communication skills, and working proficiency with CTMS tools.

Desirable experience

• Hands-on experience using CRIO CTMS.
• A tertiary qualification in health, life sciences, or a related discipline.
• Experience working on Phase II or Phase III studies across different therapeutic areas.

Additional information

This position is based onsite in Woolloongabba, Brisbane. The role is available on a part-time basis and may also be structured as full-time. A small, growing team environment means initiative, flexibility, and ownership are especially valued.