Clinical Research Associate Role
We are seeking a highly skilled Clinical Research Associate to support the management of clinical studies for state-of-the-art implantable medical devices.
The ideal candidate will have excellent communication skills and the ability to work effectively as part of a cross-functional team.
This role will involve assisting with the planning, execution and closure of both pre-market and post-market clinical studies.
The successful candidate will be responsible for developing and approving study-specific documents, preparing ethics submissions and study reports, and participating in site qualification and study initiation processes.
* Developing and approving study-specific documents, tools, presentations and processes
* Maintaining Trial Master Files and Investigator Site Files for multiple studies
* Preparing and presenting at Investigator meetings
* Participating in site qualification, study initiation and study closure process
* Assisting with the management of medical device tracking and accountability
* Creating and maintaining study databases, including data entry, routinely reviewing data/CRFs to ensure data integrity, accuracy and protocol compliance
* Tracking and reporting progress of studies to applicable internal stakeholders
* Developing study reports and providing clinical reports for regulatory submissions
The ideal candidate will possess a Bachelor's degree in Science or related disciplines and a minimum of 4 years of experience in the medical device industry.
Experience in pre-market and post-market clinical studies of medical devices is essential, and clinical certifications desirable.
A proven track record of successfully managing projects to deadlines, strong problem-solving and communication skills, self-motivation, high organisation and attention to detail are all essential.
This is an exciting opportunity to develop your experience and career in a dynamic company.