Coordinate clinical study activities including planning, start-up, drafting laboratory manuals and reports, liaising with clients and partners, maintaining records to accreditation standards (NATA/ISO/GLP/GCLP), supporting project tracking and meetings, and producing internal and client reports.
360biolabs is Australia's most comprehensive quality-accredited specialty laboratory services organisation. 360biolabs is a BioAgilytix company and part of a leading global contract research organisation (CRO) supporting the development of innovative new medicines in a quality-controlled environment. At 360biolabs, we develop and conduct pharmacokinetics (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas to ensure the success of our clients' clinical trials and preclinical studies.
Working at 360biolabs means working with the best people (and technology) in our field. With a genuine focus on development, you will have access to local and global opportunities. You will also have access to a diverse offering of wellbeing and connection initiatives which reflects that people are our priority.
Assist in the coordination of clinical projects supported by 360biolabs. Responsible for drafting clinical study associated documentation and supporting the day to day conduct of high-quality collaborative R&D at 360biolabs for clients to NATA R&D and SOP requirements.
Key Responsibility Areas
- The key responsibility areas (KRAs) are the major outputs for which the position is responsible and are not a comprehensive statement of the position activities.
- Assist in the planning and start-up activities associated with the implementation of new clinical studies
- Draft and review reports related to clinical study laboratory manuals, analytical protocols and reports
- Liaise and coordinate with colleagues, partner organisations and client representatives to ensure activities are aligned to deliver goals
- Provide study coordination to clinical project teams
- Contribute to clinical project and team meetings as appropriate to aid with project tracking and reporting
- Coordinate and actively participate in company meetings including project and client management
- Compile and review reports on clinical activities, timelines and outcomes
- Maintain records to levels consistent with relevant standards
- Assist in the production of both internal reports and reports for clients
- Adhere to ISO/IEC 17025, OECD Principles of GLP, GCLP Principles, 360biolabs’ Quality Management System, and other requirements as per NATA Accreditation and regulatory guidelines
- Maintain high levels of communication with colleagues and maintain productive relationships with clients, CROs, collaborators and partners
- Attend meetings associated with clinical research and the work of 360biolabs
- Participate in professional activities including attendance at training courses and seminars as required
Clinical Project Coordination
Data Analysis, Reporting, and Document Work
NATA Accreditation
Teamwork
Professional Development
Key Selection Criteria
- Bachelor of Science (Hons) or equivalent qualification plus relevant experience (Essential)
Experience / Knowledge / Attributes
- Experience in medical laboratory techniques (Essential)
- Excellent organisational and writing skills (Essential)
- Ability to work as part of a team (Essential)
- Good communication skills (Essential)
- Proficient in use of Word Office, including Word, Excel, and PowerPoint (Essential)
- Experience with database software and file management (Essential)
- Experience in the conduct of clinical trials (Desirable)
- High motivation and enthusiasm for medical research and drug development (Desirable)
For further information, please contact our Careers Team ([email protected]). Please submit your application via the job link if you're interested in joining us, as we’re not able to process applications sent by email.
Apply now if you have what it takes to join our team!
360biolabs is a flexible, equal opportunity employer looking for committed and like-minded people to join us. Our culture is something we are very proud of, celebrating each individual and everything they bring to our team. We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQIA+ community and people with a disability.
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To express your interest in this position please submit a CV and cover letter. Applications only accepted from Australian / NZ residents with valid Australian work rights.
#360biolabs
BioAgilytix Melbourne, Victoria, AUS Office
85 Commercial Road, Melbourne, Australia
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