Clinical Trial Project Manager
- 0.4 FTE, part time, fixed term until March 2027
- Oversees clinical trial projects to support the National Health and Medical Research Council (NHMRC) funded COMFORT trial
- Base Salary $ 97,975 - pro rata + 17% superannuation
About the opportunity
Sydney Musculoskeletal Health is an academic research organisation that runs studies to improve global health outcomes. We do this by bringing together world-leading experts in trials (design, methods, and conduct), biostatistics, patient-reported outcomes, health economics, translational research, research synthesis, and health technology assessment. Collaborative partnerships help us to ensure trial results best inform clinical practice.
Sydney Musculoskeletal Health is a flagship research centre within the University of Sydney's Faculty of Medicine and Health (FMH). Our researchers work collaboratively with researchers within the FMH and across the University to advance the quality and effectiveness of research.
The Clinical Trials Project Manager will ensure successful completion of the COMFORT trial - a trial designed to support general practitioners optimise the management of people with low back pain. They will have oversight of budget, stakeholder engagement, ethics, risk management, professional development and training of junior staff, monitoring and reporting, facilitating site recruitment, study start up and study closure (among other responsibilities).
Your key responsibilities will be to:
- lead the structural and operational establishment of the trial and manage stakeholder engagement, ethics and governance
- oversee stakeholder engagement and co-ordinate regular communication with the clinical trial investigators
- support the steering committee and research personnel in the development and execution of research projects.
- work with researchers and sites to implement research protocols and provide day-to-day management support to the research team
- assist with preparation, development and submission of reports to NHMRC, funding applications, research grants and publications
- provide guidance and support to researchers in the development of applications for grants, fellowships or other sources of external funding
- oversee preparation of material for submission to ethics committees
- manage the establishment and maintenance of a research database
- undertake continuing professional development activities in relation to research
- supervise junior researchers and oversee the recruitment of research personnel across participating sites
- BSc or equivalent with relevant experience in related field, may have (or be working towards) completing further studies such as PhD or have extensive specialist experience in the field of research
- has an understanding and/or certification of GCP guidelines and protocol requirements for clinical trials
- current Good Clinical Practice certification
- demonstrated understanding of primary care, back pain, opioid medications and its link to general health
- has experience working as project manager on a clinical trial in a health discipline
- has extensive experience in developing and working on research projects, including expertise in developing research protocols, experimental design, ethics submissions and preferably, grant applications
- has experience with PBS/MBS data and submission of governance approval forms to Department of Human Services and CHeReL
- has demonstrated experience in basic clinical trials, health/ medical science administration or experience in a similar field
- has experience with database and content management systems in a research, health or related environment
- has experience preparing risk assessment, ethics application and clinical documentation
- demonstrated experience in providing high levels of clinical trial accuracy
- demonstrated experience in managing large budgets
- must be willing to travel and has an Australian Drivers Licence.
To keep our community safe please be aware of our COVID safety precautions, which form our conditions of entry for all staff, students and visitors coming to campus.
Closing date for applications
11:59 pm, Sunday 30 January 2022
Sponsorship / work rights for Australia
Please note: Visa sponsorship is not available for this position. For a continuing position, you must be an Australian or New Zealand citizen or an Australian Permanent Resident.
Australian Temporary Residents currently employed at the University of Sydney may be considered for a fixed term contract for the length of their visa, depending on the requirements of the hiring area and the position.
Your employment is conditional upon the completion of all role required pre-employment or background checks in terms satisfactory to the University. Similarly, your ongoing employment is conditional upon the satisfactory maintenance of all relevant clearances and background check requirements. If you do not meet these conditions, the University may take any necessary step, including the termination of your employment.
At the University of Sydney, our shared values include diversity and inclusion and we strive to be a place where everyone can thrive. We are committed to creating a University community which reflects the wider community that we serve. We deliver on this commitment through our people and culture programs, as well as key strategies to increase participation and support the careers of Aboriginal and Torres Strait Islander People, women, people living with a disability, people from culturally and linguistically diverse backgrounds, and those who identify as LGBTIQ. We welcome applications from candidates from all backgrounds.
How to apply
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