Clinical Project Coordinator/Clinical Trial Assistant
CTI Clinical Trial and Consulting Services · Sydney, New South Wales, Australia
- On site
- Full-time
- $65,000 / year
- Sydney, New South Wales, Australia
Job highlights
- Support clinical project management activities.
- Assist with project documentation and reporting.
- Track project progress and site activities.
- Collaborate with internal teams and external sites.
- Contribute to clinical trial start-up and operations.
About the role
Clinical Project Coordinator
CTI Clinical Trial and Consulting Services is seeking a motivated Clinical Project Coordinator to join our team.
What You'll Do
- Support Clinical Project Managers / Directors in completing management activities across all phases of a clinical project, providing back-up management as needed.
- Update Clinical Project Managers / Directors on progress, outstanding items, and issues, and assist with issue resolution.
- Assist with preparing data reports for site and Clinical Research Associate (CRA) management and support site management activities.
- Develop initial drafts of clinical project plans, manuals, presentations, and other project documents, and assist in their review and maintenance per CTI Standard Operating Procedures (SOPs).
- Prepare initial drafts of internal and external reports, newsletters, and other project communications, and distribute them to relevant parties.
- Assist with tracking project scope and internal financial reporting.
- Prepare initial drafts of detailed meeting agendas and minutes, assist in reviewing meeting documents, and attend routine internal and external team meetings.
- Monitor and maintain tracking tools, clinical systems, and shared document repositories used for clinical project management.
- Support the review and tracking of site pre-screening, screening, and enrollment activities, as well as subject status information, following up on any identified issues.
- Support tracking of action items and internal team follow-up.
- Prepare and maintain tracking of clinical project start-up activities and milestones, including site selection and start-up.
- Assist the clinical project team with developing feasibility surveys and content, participate in feasibility calls, and assist with site follow-up during start-up.
- Assist with documenting clinical project and SOP-related deviations.
- Support and maintain clinical project documents in paper and/or electronic Trial Master Files (TMFs) and assist with TMF reconciliation and period review follow-up.
- Participate in preparing for and following up from internal and external audits, and participate in audits as needed.
- Assist with the management of all clinical project-related supplies and drug management.
- Provide support to other departments as needed throughout all phases of clinical projects.
- Provide support in developing new Clinical Project Coordinators, Clinical Project Assistants, and Research Associates (RAs).
- Assist with orientating new Clinical staff.
- Provide third-party vendor support.
- Represent CTI professionally and foster collaboration with all clinical project teams and functional departments.
What You'll Bring
- Bachelor’s degree in allied health fields (nursing, pharmacy, health/natural science) or an equivalent combination of education and relevant work experience.
- Minimum of 1 to 3 years of experience in a clinical research related field.
Why CTI?
- Career Progression: We promote from within, with a structured mentoring program and initiatives for recent graduates.
- Education & Training: We offer tuition assistance, university partnerships, and a dedicated training department.
- People Value: Guaranteed full pay during COVID-19 shutdowns, generous vacation time, and a hybrid work-from-home schedule support work-life balance.
- Unparalleled Culture: Recognized as a best place to work and a top CRO.
- Global Reach, Local Connection: Employees in 60 countries with strong local community ties via CTI Cares Committees.
- Future-Oriented: Consistent double-digit growth, investment in cutting-edge technology, and a 95% average annual retention rate.
- Meaningful Work: Focus on treatments for chronically and critically-ill patients, bringing life-changing therapies to market.
Key skills/competency
- Clinical Project Management
- Clinical Trial Operations
- Regulatory Affairs
- Data Management
- TMF Management
- Site Management
- Clinical Research Associate
- Project Planning
- Budget Tracking
- Vendor Management
Skills & topics
- Clinical Project Coordinator
- Clinical Trial Assistant
- Clinical Research
- Project Management
- CRO
- Clinical Operations
- Regulatory Affairs
- Data Management
- Trial Master File
- Healthcare
How to get hired
- Tailor your resume: Highlight your 1-3 years of clinical research experience and Bachelor's degree.
- Showcase transferable skills: Emphasize organizational, communication, and project support abilities.
- Research CTI's culture: Understand their commitment to career progression, education, and work-life balance.
- Prepare for interviews: Be ready to discuss your experience with clinical project documentation and tracking.
- Follow instructions: Ensure your application clearly demonstrates alignment with CTI's SOPs and values.
Technical preparation
Familiarize yourself with clinical trial phases.,Understand CTI's SOPs and documentation requirements.,Practice using clinical trial management systems.,Review data reporting and tracking tools.
Behavioral questions
Describe a time you supported a project manager.,How do you handle conflicting priorities?,Give an example of proactive issue resolution.,How do you ensure documentation accuracy?
Frequently asked questions
- What is the primary role of a Clinical Project Coordinator at CTI?
- A Clinical Project Coordinator at CTI primarily supports Clinical Project Managers/Directors in managing all aspects of clinical projects. This includes assisting with documentation, reporting, tracking progress, site management, and ensuring adherence to Standard Operating Procedures (SOPs).
- What educational background is required for the Clinical Project Coordinator role at CTI?
- CTI requires a Bachelor’s degree in allied health fields such as nursing, pharmacy, or health/natural science. An equivalent combination of education and relevant work experience will also be considered.
- How much experience is needed to be considered for the Clinical Project Coordinator position?
- Candidates should have a minimum of 1 to 3 years of experience in a clinical research-related field to be considered for this Clinical Project Coordinator role.
- Does CTI offer opportunities for career advancement for Clinical Project Coordinators?
- Yes, CTI emphasizes career progression by promoting from within. They offer a structured mentoring program and specific programs for recent graduates to support employee advancement.
- What is the work arrangement for a Clinical Project Coordinator at CTI?
- CTI offers a hybrid work-from-home schedule, supporting a work-life balance for its employees.
- What kind of clinical projects does CTI focus on?
- CTI focuses its work on treatments for chronically and critically-ill patients, aiming to bring life-changing therapies to market.
- How does CTI support employee education and training?
- CTI values education and training by providing tuition assistance, partnering with universities, and having a dedicated training department.
- What does 'support for site management activities' entail for a Clinical Project Coordinator?
- This includes assisting with preparing data reports for site management, tracking screening and enrollment activities, monitoring subject status, and following up with sites on any issues that arise for the Clinical Project Coordinator.