Are you ready to discover your career potential with Covance?
We are seeking exceptional Clinical Research Associates (CRAs) to join our growing Clinical Operations team in Australia.
You will monitor sites across Australia and have the flexibility to work from home.
You will be employed permanently by Covance.
If you are passionate about Clinical Research and a person who has experience independently monitoring Phase I - IV clinical study sites in Australia, let’s talk as we have a role for you.
Your responsibilities will include:
- Leading all aspects of study site monitoring according to Covance SOP, GCP, and ICH guidelines
- Partner with investigators and study coordinators on pre-study qualification and site initiation visits
- Conduct routine study site monitoring visits
- Close-out clinical sites, and ensure study files are up to date to maintain the success of the study.
Covance Australia is committed to providing Clinical Research Associates; flexibility to work from home, the freedom to grow your career across all phases and areas of clinical trial operations, and provides you with cutting edge technology and processes that help to manage your time and workload.
Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region.Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
At Covance, you will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
Discover your potential in a company that truly invests in you. Talk to us to learn more and explore your career. Apply online today.
- Degree Qualified
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event (SAE) reporting
- Typically 3+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
- Knowledge of the Australian site and regulatory environment is beneficial
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
• In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered
• Thorough knowledge of regulatory requirements
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal
• Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
• Thorough knowledge of company SOPs regarding site monitoring
- Three-Four (3-4) years of Clinical Monitoring experience
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Advanced site monitoring skills
- Advanced study site management skills
- Advanced registry administration skills
- Ability to work with minimal supervision
- Good planning and organization skills
- Good computer skills with good working knowledge of a range of computer packages
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritizes workload for self and team
- Ability to work within a project team
- Works efficiently and effectively in a matrix environment
- Valid Driver's License
- One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
- Local project coordination and/or project management experience
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