Full-time fixed term role for 12 months at Camperdown - possibility of extension subject to fundingClinical Trial Study Coordinator role with the Health and Clinical Analytics team at the School of Public HealthBase Salary $ 117,133 + 17% superannuationAbout the opportunityThe 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.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 .
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.Your key responsibilities will be to:coordinate the establishment, implementation and ongoing delivery of the MARS study, ensuring project objectives, timelines and milestones are achievedoversee 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 standardscollaborate effectively with cross-functional teams including investigators, clinicians, statisticians, cystic fibrosis networks, research partners, vendors and other key stakeholders to support successful study deliverymanage interactions with contributing investigators and collaborators regarding protocol development,



study systems and implementation activitiescoordinate meetings and communications with investigators, consumers, data managers, analytics teams, Data Safety Monitoring Committees and other trial stakeholderslead the preparation and management of clinical trial documentation, ethics and governance submissions, regulatory records and essential trial documentationmonitor project performance, identify and mitigate risks, and implement governance processes to support the successful delivery of the MARS studyprepare project progress reports and communicate study updates to investigators, funding bodies, governance committees and other stakeholders as requiredmonitor project budgets, resource allocation and expenditure to ensure effective financial management and reporting of clinical trial activitiescontribute to continuous quality improvement, audit readiness and compliance activities across the clinical trial portfolioAbout youdegree qualifications in health, science, public health, biomedical science or a related discipline, with postgraduate qualifications highly regardedsubstantial experience coordinating or managing clinical trials across multiple sites, including investigator-initiated studies and complex clinical research programsdemonstrated experience leading clinical trial start-up activities, including protocol implementation, ethics and governance submissions, site feasibility, site selection and site agreement processesdemonstrated experience in clinical trial data management,



including data collection, data validation, data cleaning and maintaining data integrity across complex clinical studiesstrong knowledge of Positive Clinical Practice (ICH-GCP), clinical trial governance and regulatory requirements, gained through managing trials in academic, hospital or industry settingsproven ability to manage multiple concurrent projects, timelines, budgets and competing priorities in a complex research environmentexperience developing and maintaining productive relationships with investigators, hospitals, research institutes, consumers and other internal and external stakeholdersdemonstrated ability to coordinate multidisciplinary teams and facilitate effective communication across study collaborators, investigators, data managers and governance committeesexperience preparing and managing clinical trial documentation, technical systems and study records to support trial delivery and compliance requirementsstrong understanding of clinical trial budgeting, resource management and financial oversightexperience contributing to continuous quality improvement activities and maintaining high standards of data integrity and research qualityexcellent written and verbal communication skills, with the ability to influence, negotiate and build effective working relationships across diverse stakeholder groupsexperience within respiratory, cystic fibrosis or other complex clinical research programs will be highly regarded.Sponsorship / work rights for AustraliaYou 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.Pre-employment checks and declarationsYo
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📌 Clinical Trial Study Coordinator-School Of Public Health (Sydney)
🏢 usyd
📍 Sydney