Clinical Trial Manager
Locations: Surgical, Treatment and Rehabilitation Services (STARS)
Time Type: Part time
Posted On: Posted 4 Days Ago
Job Requisition ID: R-43497
STARS Education and Research Alliance
Part-time (80%) fixed-term position through to September 2028
Base salary will be in the range $111,154 - $124,619 + 17% Superannuation (HEW Level 8)
Based at the STARS Hospital building, Herston, Brisbane
About This Opportunity
We are seeking an experienced Clinical Trial Manager to join the Surgical Treatment and Rehabilitation Services (STARS) Education and Research Alliance team. In this role, you will provide specialised project management and clinical trial management skills for a national, multi-site, randomised clinical trial. The FISS-Australia Trial, funded by an NHMRC-NIHR Collaborative grant, will compare the clinical and cost-effectiveness of the Action Falls rehabilitation programme compared to usual care alone to reduce falls in stroke survivors.
Our ideal candidate will be responsible for:
- Ensuring the highest standards of trial management, research governance and ethics compliance
- Developing, monitoring, and reporting on the project plan for the trial
- Drafting trial specific protocols and processes
You will ensure that all aspects of the clinical trial are in accordance with Good Clinical Practice guidelines, Standard Operating Procedures, local and international regulatory requirements and that study specific requirements including protocols and ethically approved study-specific documents are adhered to. You will participate in collaborative multi-disciplinary research activities with internal and external collaborators, across trial sites in Queensland and other Australian states. You will participate in collaborative research activities with the FISS-UK trial team as we are conducting two trials in collaboration. Some interstate travel may be required to complete site visits.
Key responsibilities will cover:
- Clinical Trial Management
- Clinical Research Projects
- Governance and Reporting
- Leadership and Management
This will include, but is not limited to:
- Developing a project plan to meet funding and partner agreements, ensuring timely completion of project milestones
- Developing and managing research project documents (ethics and governance submissions, study protocols, case report forms, presentations for meetings)
- Performing clinical data review listings and summary tables, including query generation and resolutions management
- Establishing a project governance framework involving parties from the University, Queensland Health, and other trial partners
- Working with the onsite staff at partner hospitals and universities, leading the establishment and supporting ongoing operation of trial sites in accordance with SOPs, protocol, and all applicable regulatory guidelines
- Developing clinical trial project documentation e.g. Trial Master File (TMP), operating procedures, protocols, site initiation documentation, etc.
- Monitoring budgets and supporting the Chief Investigator with project finances
- Maintaining communication with collaborators, trial sites and key stakeholders, including organising and actively participating in meetings and trainings
About UQ
As part of the UQ community, you will have the opportunity to work alongside the brightest minds, who have joined us from all over the world.
Everyone here has a role to play. As a member of our professional staff cohort, you will be actively involved in working towards our vision of a better world. By supporting the academic endeavour across teaching, research, and the student life, you will have the opportunity to contribute to activities that have a lasting impact on our community.
Join a community where excellence is at the core of our culture, contributions are valued and a range of benefits and rewards are available, such as:
- 26 weeks paid parental leave or 14 weeks paid primary caregiver leave
- 17% superannuation contributions
- 17.5% annual leave loading
- Access to flexible working arrangements including hybrid working options and flexible start/finish times
- Health and wellness discounts – fitness passport access, free yearly flu vaccinations, discounted health insurance, and access to our Employee Assistance Program for staff and their immediate family
- UQ Study for Staff
- Salary packaging options
About You
Postgraduate Tertiary qualifications, preferably in a science or health care discipline or relevant senior experience working in a science or health setting.
Previous and relevant experience working on clinical research projects within an academic, CRO or pharmaceutical environment.
Strong experience in project management and conducting complex multi-site clinical trials in accordance with GCP methodology including evidence of management of project budget/s >$1million.
Experience in feasibility analyses, budget management, site start up and all aspects of trial management through to close-out activities.
Demonstrated knowledge of Australian and international regulatory requirements for clinical trials and clinical research.
Highly collaborative with good stakeholder management skills, strategic thinking and analytical skills, along with strong organisational, communication and planning skills.
Excellent interpersonal skills and the ability to work well and flexibly with a wide range of varying stakeholders.
Experience with the Redcap Database.
Previous experience with clinical site initiations and clinical site monitoring.
Strong focus on quality of work.
Proficient in use of the Microsoft office suite and clinical trial management systems and an ability to learn new systems as required.
Senior Clinical Research Associates, Project Managers and/or applicants with prior Contract Research Organisation experience will be highly regarded.
The successful candidate may be required to complete a number of pre-employment checks, including: right to work in Australia, criminal check, education check, and mandatory immunisations.
Work Rights
You must maintain unrestricted work rights in Australia for the duration of this appointment to apply. Visa sponsorship is not available for this appointment.
Relocating from interstate? There may be a possibility of a relocation support package. You can find out more about life in Australia’s Sunshine State here.
Questions?
For more information about this opportunity, please contact Dr Emmah Doig at e.doig@uq.edu.au. For application queries, please contact talent@uq.edu.au stating the job reference number (below) in the subject line.
Want to Apply?
All applicants must upload the following documents in order for your application to be considered:
- Cover letter summarising how your background aligns to the ‘About You’ section
- Resume
Other Information
UQ is committed to a fair, equitable and inclusive selection process, which recognises that some applicants may face additional barriers and challenges which have impacted and/or continue to impact their career trajectory. Candidates who don’t meet all criteria are encouraged to apply and demonstrate their potential. The selection panel considers both potential and performance relative to opportunities when assessing suitability for the role.
We know one of our strengths as an institution lies in our diverse colleagues. We're dedicated to equity, diversity, and inclusion, fostering an environment that mirrors our wider community. We're committed to attracting, retaining, and promoting diverse talent. Reach out to talent@uq.edu.au for accessibility support or adjustments.
Applications close Sunday 3rd November 2024 at 11.00pm AEST (R-43497). Interviews are tentatively scheduled for week commencing 11th November 2024.
Acknowledgment of Country:
The University of Queensland (UQ) acknowledges the Traditional Owners and their custodianship of the lands on which UQ is situated. We pay our respects to their Ancestors and their descendants, who continue cultural and spiritual connections to Country.
Why Choose UQ?
At the University of Queensland, we are proud to be one of Australia’s leading research and teaching institutions, consistently ranking among the top 50 universities worldwide.
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UQ is dedicated to supporting the career aspirations of our students and staff. Our comprehensive career services provide personalized guidance, skills development, and networking opportunities to help you achieve your professional goals. Whether you are a student seeking internships and job placements or a staff member looking for career advancement, UQ is here to support you every step of the way.
Diverse and Inclusive Community:
UQ values equity, diversity and inclusion and seeks to reflect the broader community by attracting and retaining high-quality staff from a range of backgrounds. Our commitment to equity, diversity, and inclusion aims to ensure that everyone at UQ feels valued and empowered to achieve their full potential. We are particularly interested to hear from people who bring diversity to UQ – whether that be gender identity, LGBTQIA+, cultural and/or linguistic, Aboriginal and/or Torres Strait Islander peoples, or people with a disability.
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