Cochlear’s mission is to help people hear and be heard. Around the world, more people choose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always.
Cochlear Asia-Pacific, the fastest growing division of Cochlear Ltd, has a direct market presence in Japan, Korea, China, India, SE Asia and Australia & New Zealand. Our implantable hearing device portfolio includes cochlear implant systems (Nucleus®) and bone conduction implant systems (Baha®).
We are seeking a Clinical Research Associate, reporting to the Clinical Research Manager, to be based in our Sydney Office. In this role, the successful Clinical Research Associate will have the opportunity to be involved in national and international clinical trials. This includes collaborating with research teams, monitoring of trials for compliance and managing clinical trial data. The Clinical Research Associate will also participate in the management of scientific communication activities such as publications, scientific congress participation planning and other data communication activities.
- Manage and monitor the progress of assigned clinical studies in compliance with Cochlear Standard Operating Procedures (SOPs) and ICH-GCP standards.
- Prepare, plan and conduct site initiation visits, feasibility assessments and investigator meetings.
- Partner with the Clinical Research Manager to manage clinical trial documentation, study protocol design and the development of the Clinical Investigation Plan for each project.
- Manage the communication links with key internal and external stakeholders (Investigators, Committee members and Research Coordinators, etc) as per the Study Communication Plan.
- Collaborate cross-culturally across APAC countries and teams to prepare ethics committee submissions.
- Lead site management acitivites
- Evolve current developmental initiatives by facilitating training for investigators and site personnel to ensure they can conduct the study accurately.
- Manage the detection and reporting of protocol deviations, implementing corrective measures as required.
- Assist with the preparation of Clinical Investigation Reports including interim reports, Ethics Committee (EC)/Institutional Review Board (IRB) updates and the Final Clinical Investigation Report.
You Bring Your Skills and Experience
As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:
- Graduate qualifications in a science related field, preferably a life science discipline.
- Certificate of Good Clinical Practice and working knowledge of the ICH-GCP guidelines.
- Minimum 2+ years experience in a similar role with good working knowledge of clinical research methodologies
- Proven ability to translate complex information to both clinical and non-clinical audiences.
- Demonstrated ability to work flexibility and independently.
- Ability to travel up to 30% in the Asia Pacific region.
- Excellent understanding of ethical frameworks.
- Strong written, verbal and presentation skills.
• Demonstrated experience working with statistical software
• Ability and experience working with electronic data capture systems in clinical research
• Membership of local professional bodies or international clinical groups
• Fluent in Mandarin (both written and spoken)
In turn, you will have the opportunity to work across a diverse, challenging and rewarding set of organisational boundaries. By supporting the management of clinical research within the world’s fastest growing region, you will be making a real difference to the lives of the hearing impaired. You will also have the unique opportunity to expand your capabilities in clinical strategy building through regional and global career progression pathways.
Working for Cochlear:
Cochlear is the global leader in the research and development, manufacture and marketing of implantable hearing solutions. Cochlear’s global headquarters is located on the campus of Macquarie University, Sydney, Australia to enable links to world leading hearing science research. A success story in the commercialisation of R&D, Cochlear has over 60% share of the global market, employs more than 3,500 people worldwide, operates directly in over 20 countries and sells in over 100 countries. Over 475,000 people across more than 100 countries now experience hearing as a recipient of a Cochlear hearing solution. Cochlear can offer:
- The Work - A high impact job supporting world leading technology
- The Organisation – A global leader in active implantable medical device hearing technology
- The Opportunity – To make a difference to the quality of people’s lives
As a world-leader in innovative medical devices, Cochlear encourages continuous learning for employees. Visit www.cochlearcareers.com for more information.
How to Apply:
Please submit your resume and a covering letter detailing your suitability for this role. All applications will be considered and qualified candidates will be contacted.