We are seeking exceptional Senior 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 also 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 company SOPs, 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.
• 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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