Clinical Trials Senior Coordinator (Queensland)

Clinical Trials Senior Coordinator (Queensland)

06 Aug
|
Heart of Australia
|
Queensland

06 Aug

Heart of Australia

Queensland

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

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