- Be part of a growing and closely knit team of clinical experts in Sleep Apnoea
- Flexible working arrangement- less travel requirement
- Liaise with global colleagues directly and work on regional studies
About the company
An innovative medical device company based in Belgium that is currently developing a novel neurostimulation technology to treat Obstructive Sleep Apnoea for patients that have failed or refused continuous positive airway pressure (CPAP) therapy.
About the opportunity
The SCRA is responsible for managing the various databases and electronic data capture tools to ensure data is available in a timely manner for periodic use by various internal and external and stakeholders as well as conduct monitoring visits at our clinical trial sites across Australia to ensure quality data is collected by researcher
- Performing start-up, initiation, monitoring and close-out visits along with maintaining appropriate documentation
- Monitoring all aspects of studies to ensure compliance with GCP, study protocol and regulatory requirements and prepare monitoring reports
- Development and review study protocols and other study related documents
- Preparing ethics submissions and assist in preparation of Clinical Study Reports.
- Support the site initiation and SIV training of study site personnel on the protocol in collaboration with project team members.
- Organize and conduct monitoring visits in line with the monitoring plan and prepare monitoring reports
- Build and maintain relationships with sites through frequent communication to ensure appropriate clinical trial oversight at the site level
- Aid in data management collected through electronic data capture.
- Manage Trial Master File for studies specific to Australia
Skills and Experience
- A degree in scientific or health discipline required, and advanced degree is preferable
- Understand and apply medical and business know-ledge to clinical trial execution.
- Min 3 years' experience in clinical research or having demonstrated adequate level of proficiency within the Sr CRA I/ II.
- Solid understanding of clinical trial design, trial execution and operations.
- Knowledge of international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
- Proven people management skills with demonstrated expertise in working on teams.
- Able to show initiative and work well autonomously, within minimal supervision.
How to Apply
Click apply or contact Mattias Fitzgerald (Ph: +61 2 8877 8749 / Email: email@example.com)-for a confidential discussion.
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