Role type : Full-time Fixed-term for 12 months
Faculty : Faculty of Medicine, Dentistry and Health Sciences
Department / School : Department of Medicine
Salary : UoM 6 - $96,459 - $104,413 % super
Your next career opportunity
As the Clinical Research Ethics Submission Specialist and Admin Support at the Diabetes Technology Research Group (DTRG), you'll play a crucial role in facilitating groundbreaking research. Based at St Vincent's Hospital, you'll lead ethics and governance submissions for clinical trials, ensuring compliance with regulatory requirements, while providing essential administrative support. This position offers you the opportunity to work with leading researchers, contribute to innovative diabetes technology studies, and drive ethical excellence in medical research.
Your responsibilities will include :
* Manage Ethics Submissions: Prepare and coordinate HREC and RGO approvals for clinical trials, including protocol development and contract execution.
* Ensure Regulatory Compliance: Oversee adherence to GCP guidelines and regulatory requirements throughout the trial lifecycle.
* Provide Administrative Support: Assist the trial management team with document preparation, communications, and meeting coordination.
* Facilitate Collaboration: Support internal and external communications to enhance research partnerships and project development.
You may be a great fit if :
You are an experienced clinical research professional with a strong background in ethics and governance submissions, possessing excellent attention to detail, administrative skills, and a thorough understanding of regulatory requirements in medical device research.
You may also :
* Have at least 12 months of experience in coordinating Human Research Ethics Applications and Governance processes.
* Possess a high-level understanding of Australian clinical and regulatory requirements for trial activation.
* Demonstrate extensive knowledge of ICH-GCP guidelines, including recent updates.
* Be proficient in using ERMS in a clinical trial environment.
* Have strong organisational and time management skills.
* Exhibit excellent communication and influencing abilities.
* Hold a tertiary qualification in Health, Life Sciences, or a related field.
* Have a sound working knowledge of medical terminology and scientific language.
What we offer you!
We offer the opportunity to be part of a vibrant community and enjoy a comprehensive range of benefits to support your success and sense of fulfillment, including :
* Supportive flexible work arrangements underpinned by our commitment to inclusion and well-being
* Progressive, considerate leave provisions to empower your work-life balance
* Salary packaging and access to a range of discounted services including Bupa health insurance
* Health and well-being services including a leading Employee Assistance Program
* Comprehensive career development and training, plus a 25% discount on UniMelb graduate courses for your immediate family members!
Your new team – Department of Medicine
Step into the world of impactful medical education and pioneering research with the Department of Medicine at the prestigious Melbourne Medical School. As a vital hub within the University of Melbourne teaching hospitals, we are at the forefront of clinical, educational, and research endeavours. Our reach spans across renowned institutions like Royal Melbourne Hospital, St Vincent’s Hospital, Austin Health, Western Health, and Northern Health, offering you a unique opportunity to contribute to cutting-edge clinical trials and innovative healthcare research.
Be Yourself
The University of Melbourne is an Equal Opportunity Employer and a child-safe organisation. We are committed to creating an inclusive and equitable workplace where all individuals feel valued, respected, and have the opportunity to thrive regardless of gender identity, ethnicity, sexual orientation, disability, age, being a parent or having caring responsibilities.
Aboriginal and Torres Strait Islander Applicants
We aspire to be the University of choice for Indigenous Australians, with unprecedented investment to attract, nurture and retain Aboriginal and Torres Strait Islander students and staff. Tangible support through a range of programs and initiatives will ensure that you personally succeed and flourish while at the University of Melbourne.
If you are a member of an Aboriginal and / or Torres Strait Islander community and would like any support, please feel free to contact our Indigenous Employment & Development team via email.
Please note : Visa sponsorship is not available for this position. This role requires current valid work rights for Australia.
Join Us and unlock your career potential!
Is this the perfect opportunity for you? Apply today! Including the following documents :
* Resume
* Cover Letter outlining your interest and experience
* The responses against the Selection Criteria (found in the Position Description)
If you have any questions regarding the recruitment process, please feel free to contact Dijana Pourgoutzidis via email, ensuring that you include the Position Number and the Job Title as the subject. Please do not share your application to this email address.
If you have any particular questions regarding the job please follow the details listed on the Position Description.
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