Clinical Research Associate/Senior Clinical Research Associate (BBBH34959) Melbourne, Australia
About the company
Our client is one of the world's largest and most comprehensive drug development services companies globally. You will work in a collaborative environment giving you an excellent overview of best practices across the industry. Our client is one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies through pivotal Phase III global clinical trials.
About the Opportunity
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
- Responsible for all aspects of site management as prescribed in the project plans
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
Skills & Experience
- University/college degree (life science preferred)
- Minimum of 18 months independent monitoring
- Research experience in pharmaceutical or CRO industries is a must
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
- Thorough knowledge of monitoring procedures
- Good understanding of the clinical trial process
- Able to adequately complete a trip report in English
- Able to work in fast paced environment.
- Good communication, interpersonal, analytical and negotiation skills
- Works efficiently and effectively in a matrix environment
How to apply:
Click apply or contact Maddy Rhodes-Laird, Recruitment Consultant on 03 9938 7101 for a confidential discussion.