Senior Clinical Research Associate

Overview:

• Work for a multinational CRO company
• Manage sites and lead clinical teams
• Work with a single sponsor on an FSP model

Benefits:

• World leading CRO with excellent development opportunities
• Work on an interesting portfolio and take on lead tasks
• Attractive salary package
• Flexible working arrangements – Home / Office based

About the company:

Working for a full service CRO that is an industry leader in providing world class solutions in pharmaceuticals and medical devices. Spanning across many therapeutic areas, this company focuses on quality and efficiency for client success. Join an inclusive team that emphasises building a professional network, investing in employees and fostering a close-knit team culture.

About the Opportunity:

The SCRA is responsible for taking on a larger and more complex studies, while executing study deliverables and mentoring junior members of staff and following international guidelines such as ICH and GCP as well as relevant local regulations. 

Duties:

• Manage timelines and budget from start up to closeout
• Train and mentor junior CRA’s
• Monitoring sites and completing reports in timely manner
• Maintaining clear lines of communication with sites
• Providing protocol and related study training to assigned sites
• Manages site performance and collaborate to complete regulatory submissions & recruitment plans

Skills and Experience:

• Must have Australian independent monitoring experience of at least 3 years
• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP
• Preferred experience in early phase I studies
• Reasonable understanding of Clinical Study Management including monitoring, study drug handling and data management
• AU working rights

Culture:

As a world renowned CRO, the company prides itself on leveraging connectivity and data driven solutions to drive success and encourages inclusion and diversity.