We are seeking an experienced Clinical Trials Senior Coordinator to manage the day-to-day operations of our Clinical Trials.

About us

Heart of Australia embodies the most creative approach to front-line specialist medical service delivery, specifically aiming to help Australian's whose lives are threatened by this nation's vast distances.

Our state of the art, custom engineered, mobile medical clinics have travelled many kilometres and saved many patients who are at risk remotely.

We are very proud of our exceptional service delivery and our strong reputation for safely and efficiently delivering our medical services in a timely and regular manner.

The Role

The Clinical Trials senior coordinator is responsible for the strategic leadership, operational management, and oversight of all clinical trial activities conducted by the organisation. The role ensures clinical trials are conducted in accordance with Good Clinical Practice (GCP), ICH guidelines, sponsor requirements, ethics approvals, and applicable regulatory standards.

The Clinical Trials Senior Coordinator leads research staff, oversees trial feasibility and site start-up activities, drives participant recruitment initiatives, manages trial finances and resources, supports Principal Investigators, and ensures the delivery of high-quality clinical research across multiple studies and sites.

Key Responsibilities include, but not limited to:

Clinical Trial Operations

- Oversee the day-to-day management of all clinical trials conducted by the organisation
- Ensure studies are conducted in accordance with approved protocols, GCP, ethics requirements, and regulatory standards
- Coordinate study start-up activities including feasibility assessments, site selection, ethics submissions, governance approvals, and site initiation
- Monitor study progress against recruitment targets, milestones, and sponsor expectations
- Ensure timely resolution of protocol deviations, audit findings, and operational issues
- Develop and implement processes to improve research efficiency and quality

Staff Leadership and Management

- Provide leadership and direction to Clinical Trial Coordinators, Research Nurses, Research Assistants, and administrative research staff
- Oversee recruitment, onboarding, training, and performance development of research personnel




- Maintain staff competency records and ensure mandatory training requirements are met
- Foster a culture of compliance, collaboration, accountability, and continuous improvement

Regulatory and Quality Management

- Maintain oversight of regulatory documentation including Investigator Site Files, Trial Master Files, Essential Documents, and study records
- Ensure compliance with ICH-GCP, NHMRC guidelines, TGA requirements, privacy legislation, and sponsor requirements
- Lead preparation for sponsor monitoring visits, audits, and regulatory inspections
- Review and implement Standard Operating Procedures (SOPs)
- Oversee quality assurance activities and corrective and preventative action plans (CAPAs)

Participant Recruitment and Retention

- Develop and implement participant recruitment strategies
- Monitor recruitment performance and identify opportunities to improve enrolment
- Ensure participant safety, confidentiality, and informed consent processes are maintained
- Support retention initiatives to maximise participant engagement and study completion

Investigator and Sponsor Liaison

- Act as the primary operational contact for sponsors, CRAs, monitors, and external stakeholders
- Support Principal Investigators in study conduct and protocol compliance
- Attend sponsor meetings, site initiation visits, and investigator meetings
- Build and maintain strong relationships with sponsors and research partners

Financial and Resource Management

- Develop and manage clinical trial budgets
- Monitor study revenue, invoices, participant reimbursements, and sponsor payments
- Ensure appropriate allocation of personnel, equipment, and research resources
- Assist with contract reviews and budget negotiations with sponsors and CROs

Data and Systems Management

- Oversee clinical trial management systems, databases, and digital source documentation
- Ensure research data are accurate, complete, contemporaneous, and audit-ready
- Monitor data quality and ensure timely query resolution




- Support implementation and optimisation of research technology platforms including CRIO and sponsor systems

Strategic Development

- Identify opportunities to expand the clinical trial portfolio
- Support feasibility assessments for new studies
- Contribute to strategic planning and growth initiatives within the research program
- Promote research activities and strengthen stakeholder engagement across rural and regional communities

Essentially, you will have the following:

- Bachelor's degree in Nursing, Health Science, Life Sciences, Clinical Research, or related discipline
- Minimum 3 years' experience in clinical trial management or senior clinical research coordination
- Demonstrated experience managing multiple clinical trials simultaneously
- Strong working knowledge of ICH-GCP, NHMRC, TGA, and ethical requirements
- Experience leading and mentoring research teams
- Excellent project management and organisational skills
- Strong financial and budget management experience
- High level communication, negotiation, and stakeholder management skills
- Proficiency using clinical trial management systems and electronic data capture platforms

It will be desirable for you to have the following:

- Postgraduate qualification in Clinical Research, Health Management, or related field
- Experience managing multi-site clinical trials
- Experience working with regional and rural healthcare delivery models
- Experience with CRIO and electronic source documentation systems
- GCP certification

Key Performance Indicators

- Achievement of participant recruitment targets
- Timely study start-up and activation
- Protocol compliance and audit readiness
- Sponsor satisfaction and site performance metrics
- Study budget management and revenue performance
- Staff training compliance and competency completion
- Data quality and query resolution timelines
- Successful completion of monitoring visits, audits, and inspections

Further information

You will be required to meet Heart of Australia’s employment criteria which may include but not be limited to a criminal history check and full medical.

This is a full-time role Monday to Friday, 8:30am to 5:00pm based in Chelmer, QLD.

This is a great opportunity to join a progressive and exceptional team.

To find out more about us, visit www.heartofaustralia.com

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📌 Clinical Trials Senior Coordinator (Queensland)
🏢 Heart of Australia
📍 Queensland