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
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)
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.
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
Skills Required
- Bachelor of Science (Hons) or equivalent qualification plus relevant experience
- Experience in medical laboratory techniques
- Excellent organisational and writing skills
- Ability to work as part of a team
- Good communication skills
- Proficient in Microsoft Word, Excel, and PowerPoint
- Experience with database software and file management
- Familiarity with ISO/IEC 17025, OECD GLP and GCLP principles and NATA accreditation requirements
- Experience in the conduct of clinical trials
- High motivation and enthusiasm for medical research and drug development
What We Do
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory. BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.
