What are the responsibilities and job description for the Clinical Trial Assistant position at Pharmaceutical Research Associates, Inc?
Overview
Role: Clinical Trial Associate
Location:Sydney, hybrid
As a Clinical Trial Associate you will have the opportunity to work with one of the world’s leading pharma & biotech companies, helping them advance new drugs and devices.
You will be part of an innovative and global Biotechnology company, who pride themselves to be one of the world's leading independent biotechnology companies. They focus on areas with unmet medical need with the ambition to help reduce the social and economic burden of disease in society today.
Responsibilities
What you will be doing:
- Supporting with preparation of submission packages (IRB/ERC, regulatory agencies)
- Trial and site administration: tracking and updating study metrics
- Setup and maintainance of TMF/eTMF, documents collection and quality check
- Liaise with clinical sites, as well as internal stakeholders
- Coordination on drug supply planning, provision and destruction process, trial equipment and materials planning and management
- Coordination of vendors ‘activities like printing, translation and other vendors’ management
- Distribution of site materials and equipment
- Organising meetings
Qualifications
You Are:
- Previous clinical trial experience (pharmaceutical or biotechnology industry or investigative site)
- BS/BA or equivalent preferred
- Working knowledge of Australian study start-up processes
- Detail-orientated, passionate and reliable
- Basic knowledge and understanding of Essential Documents, CFR and GCP/ICH
- Proficiency with technological systems (Microsoft Office, TMF, CTMS,)
What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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