We are excited to announce an opportunity for an
Ethics and Regulatory Specialist
to join our dynamic team at Nucleus Network.
As the only global phase 1 clinical trials specialist with facilities in both the USA, UK and Australia, we are committed to "advancing medicine and improving lives" by attracting exceptional talent.
Since our founding in ****, Nucleus Network has successfully conducted over **** phase 1 clinical trials for biotechnology and pharmaceutical companies from the USA, Europe, Australia, Japan, South Korea, Taiwan, and China.
Our organization is characterized by our core values, outstanding work culture, dedication to staff development, and commitment to providing an optimal work environment.
Join us on this exciting journey of growth and gain world-class experience working with some of the most innovative biotechnology and pharmaceutical companies globally.
About the role
The
Ethics and Regulatory Specialist
is responsible for ensuring effective coordination of the ethics submission process for clinical trials at Nucleus Network.
Key responsibilities
Oversee start-up activities and be the point of contact for ethics-related decisions and activities
Coordinate ethics submissions and amendments
Liaise and build close working relationships with internal and external stakeholders
Maintain up to date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation
Ensure all essential study documentation related to ethics submissions and approvals are kept up to date for wider Project Teams
Requirements
Bachelor's degree in life sciences or related field
Exceptional written communication skills,



specifically technical writing; (thesis or research papers) in an honours or Masters setting (desired)
Comprehensive knowledge of ICH/GCP guidelines and all applicable regulatory requirements
Excellent working knowledge of HREC and IRB submission process and requirements
Effective time management skills and the ability to work to deadlines
Able to work independently and effectively in a team
An eye for detail to ensure accuracy in critical essential document preparation
Meaningful Impact
-'advancing medicine, improving lives'of people around the world
Professional Growth Opportunities -
We believe in investing in our employees' development
Employee Recognition -
Your hard work and achievements will be recognised and rewarded
Employee Wellness Initiatives -
We prioritize the health and wellbeing of our employee
Adaptable work options –
hybrid/remote work arrangements are available
Our commitment to improving lives involves creating a supportive and inclusive space where every individual feels they can be their full selves. This policy applies to all aspects of employment within Nucleus Network including our hiring and selection process. We are an equal opportunity employer, making hiring decisions based on merit and business needs at the time. We want people who embody our values of drive, teamwork, customer focus and excellence.
At Nucleus Network, we recognize our responsibility to ensurethe safety of our staff, participants, and visitors. As such, Nucleus Network requires all employees to be vaccinated against COVID-19. Vaccination evidence must be provided before the commencement date.
For more information about Nucleus Network, go to nucleusnetwork.com.au.
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📌 Ethics And Regulatory Specialist (Melbourne)
🏢 Nucleus Network
📍 Melbourne