Clinical Research Associate (CRA) / Field Clinical Specialist (FCS)

Avania are hiring for the key role of experienced Clinical Research Associate (CRA) / Field Clinical Specialist (FCS) - Based Sydney

As a CRA/FCS you will be the lead for several studies running in parallel, in all associated clinical trial phases, from regulatory submissions to close out visits, from site management to sponsor management

As a CRA/FCS you will:

• Be responsible for the start-up and initiation of Clinical Investigations including application processes to ethics committees and national competent authorities, preparation and conduct of site monitoring, site management and close out activities.
• Be the study lead for several studies.
• Act as main point of contact for the sponsor.
• Manage small clinical Investigations independently.
• Ensure coordination of a larger Clinical Investigations in collaboration with other CRAs and contractors together with a Project Manager.
• Train study sites on performing Clinical Investigations.
• Identify problems and risks that interfere with project progress, implement strategies to resolve issues in cooperation of a Project Manager. Work on site-level to ensure timely resolution of issues found during visits.
• Organize and actively participate in sponsor, investigator and project meetings.
• Provide consistent reports and updates to all team members and management (in team meetings) by keeping the Project Manager informed and assist Project Manager in managing the project.
• Be involved in Task Forces and may obtain special initiatives such as acting as a ‘Subject Matter Expert’.

Working for Avania is working in a diverse environment; from performing first in human pivotal studies to post market studies, with start-ups to multinationals. All within a broad spectrum of diverse medical devices, IVDs, biologics, and device-drug combination products, internationally with a customized approach