- Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project; provide back-up management as needed
- Update Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support Clinical Project Manager / Director with issue resolution
- Assist Clinical Project Manager / Director with preparing data reports for site and Clinical Research Associate (CRA) management; provide support for site management activities
- Develop initial drafts of clinical project plans, manuals, presentations, and other clinical project documents; assist in reviewing and maintaining these presentations and documents as required per CTI Standard Operating Procedures (SOPs)
- Prepare initial drafts, including templates and content, of internal reports, external reports, newsletters, and other clinical project communications; distribute reports and communications to sites, vendors, Sponsors, and internal team members
- Assist with tracking project scope and internal financial reporting
- Prepare initial drafts of detailed meeting agendas and minutes; assist in initial review of meeting documents prepared by others; attend routine internal and external team meetings
- Monitor and maintain tracking tools, clinical systems and shared document repositories utilized for clinical project management
- Support the review and tracking of site pre-screening, screening, and enrollment activities as well as subject status information; follow up with internal clinical project team and/or sites as necessary regarding any identified issues
- Support tracking of action items and internal team follow-up
- Support and prepare / maintain tracking of clinical project start-up activities and milestones,



including site selection and site start-up activities
- Assist the clinical project team with developing feasibility surveys and survey content; participate in feasibility calls; assist with any site follow-up needed throughout start-up
- Assist Clinical Project Manager / Director with documenting clinical project and Standard Operating Procedure (SOP)-related deviations
- Support and maintain clinical project documents in paper and/or electronic Trial Master Files and support Clinical Project Manager / Director with TMF reconciliation and period review follow-up
- Participate in preparing and following-up from internal and external audits; participate in audits as needed
- Assist with the management of all clinical project-related supplies and drug management
- Assist other departments as needed throughout all phases of clinical projects (e.g., Regulatory Affairs Study Start-up, Data Management, Safety, etc.)
- Provide support in developing current Clinical Project Coordinators, Clinical Project Assistants, and Research Associates (RAs) in clinical projects
- Assist with orientating new Clinical staff
- Provide third party vendor support
- Represent CTI in professional manner and foster collaboration with all clinical project teams / functional departments; assist in promoting interdepartmental cohesiveness

What You'll Do




- Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project; provide back-up management as needed
- Update Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support Clinical Project Manager / Director with issue resolution
- Assist Clinical Project Manager / Director with preparing data reports for site and Clinical Research Associate (CRA) management; provide support for site management activities
- Develop initial drafts of clinical project plans, manuals, presentations, and other clinical project documents; assist in reviewing and maintaining these presentations and documents as required per CTI Standard Operating Procedures (SOPs)
- Prepare initial drafts, including templates and content, of internal reports, external reports, newsletters, and other clinical project communications; distribute reports and communications to sites, vendors, Sponsors, and internal team members
- Assist with tracking project scope and internal financial reporting
- Prepare initial drafts of detailed meeting agendas and minutes; assist in initial review of meeting documents prepared by others; attend routine internal and external team meetings
- Monitor and maintain tracking tools, clinical systems and shared document repositories utilized for clinical project management
- Support the review and tracking of site pre-screening, screening, and enrollment activities as well as subject status information; follow up with internal clinical project team and/or sites as necessary regarding any identified issues
- Support tracking of action items and internal team follow-up
- Support and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activities
- Ass

📌 Clinical Project Coordinator/Clinical Trial Assistant (Sydney)
🏢 CTI Clinical Trial and Consulting Services
📍 Sydney