Job Description
Full-time fixed term role for 12 months at Camperdown - possibility of extension subject to funding
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Clinical Trial Study Coordinator role with the Health and Clinical Analytics team at the School of Public Health
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Base Salary $ 117,133 + 17% superannuation
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About the opportunity
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The Health and Clinical Analytics (HCA) team designs and coordinates a broad and growing portfolio of practice-changing trials and other clinical studies. This dynamic and cross-disciplinary team takes pride in its reputation for delivering innovative research of the highest standard.
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The team work to support a growing network of clinicians, researchers and community members with a shared motive to improve health through novel approaches to clinical research backed by cutting-edge analytics. Read more about the team here Health and Clinical Analytics .
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The Clinical Trial Study Coordinator will play a key role in supporting the project coordination of the MARS study, a trial within the BEAT-CF platform in cystic fibrosis and associated clinical research projects.
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Your key responsibilities will be to:
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coordinate the establishment, implementation and ongoing delivery of the MARS study, ensuring project objectives, timelines and milestones are achieved
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oversee the day-to-day operational management of the clinical trial, ensuring studies are conducted in accordance with protocol requirements, Good Clinical Practice (GCP) and regulatory standards
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collaborate effectively with cross-functional teams including investigators, clinicians, statisticians, cystic fibrosis networks, research partners, vendors and other key stakeholders to support successful study delivery
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manage interactions with contributing investigators and collaborators regarding protocol development, study systems and implementation activities
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coordinate meetings and communications with investigators, consumers, data managers, analytics teams, Data Safety Monitoring Committees and other trial stakeholders
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lead the preparation and management of clinical trial documentation, ethics and governance submissions, regulatory records and essential trial documentation
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monitor project performance, identify and mitigate risks, and implement governance processes to support the successful delivery of the MARS study
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prepare project progress reports and communicate study updates to investigators, funding bodies, governance committees and other stakeholders as required
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monitor project budgets, resource allocation and expenditure to ensure effective financial management and reporting of clinical trial activities
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contribute to continuous quality improvement, audit readiness and compliance activities across the clinical trial portfolio
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About you
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degree qualifications in health, science, public health, biomedical science or a related discipline, with postgraduate qualifications highly regarded
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substantial experience coordinating or managing clinical trials across multiple sites, including investigator-initiated studies and complex clinical research programs
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demonstrated experience leading clinical trial start-up activities, including protocol implementation, ethics and governance submissions, site feasibility, site selection and site agreement processes
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demonstrated experience in clinical trial data management, including data collection, data validation, data cleaning and maintaining data integrity across complex clinical studies
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strong knowledge of Good Clinical Practice (ICH-GCP), clinical trial governance and regulatory requirements, gained through managing trials in academic, hospital or industry settings
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proven ability to manage multiple concurrent projects, timelines, budgets and competing priorities in a complex research environment
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experience developing and maintaining productive relationships with investigators, hospitals, research institutes, consumers and other internal and external stakeholders
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demonstrated ability to coordinate multidisciplinary teams and facilitate effective communication across study collaborators, investigators, data managers and governance committees
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experience preparing and managing clinical trial documentation, technical systems and study records to support trial delivery and compliance requirements
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robust understanding of clinical trial budgeting, resource management and financial oversight
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experience contributing to continuous quality improvement activities and maintaining high standards of data integrity and research quality
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excellent written and verbal communication skills, with the ability to influence, negotiate and build effective working relationships across diverse stakeholder groups
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experience within respiratory, cystic fibrosis or other complex clinical research programs will be highly regarded.
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Sponsorship / work rights for Australia
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You must have unrestricted work rights in Australia for the duration of this employment to be eligible to apply. Visa sponsorship is not available for this appointment.
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Pre-employment checks and declarations
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📌 Clinical Trial Study Coordinator-School Of Public Health (New South Wales)
🏢 usyd
📍 New South Wales