Clinical Research Associate
Job no: 612431
Work type: Permanent
Categories: Clinical Studies, Western Europe, Individual Contributor
Cochlear is the global market leader in implant hearing solutions and is a top 50 company on the ASX. Cochlear's mission is to help people Hear and Be Heard.
Our Clinical Affairs & Research EMEA department is currently looking for a Clinical Research Associate for a permanent role in our location in Basel.
Could you see yourself using your experience and abilities to ensure high quality clinical investigations that will help bring life-changing hearing solutions to the hearing impaired? This is also a fantastic opportunity to contribute to the success of a global team during a period of growth and expanding capabilities with potential progression to a role with further specialisation in clinical research.
The Clinical Research Associate (CRA) supports in close collaboration with the respective Clinical Project Manager (CPM) the conduct of company sponsored clinical investigations from the planning, execution to close-out phase. The Clinical Research Associate facilitates administrative and data management tasks while assuring strict compliance to the procedures governing Clinical Affairs and Research in EMEA.
Duties and Responsibilities:
Controlled Market Release and Post-Market Clinical Follow-up programme:
- Develop and manage questionnaires and surveys within the data collection tools used, in adherence with Cochlear quality standards (data privacy, brand guidelines, templates, etc.)
- Manage data generated via questionnaires/surveys or other sources, create and maintain summaries, e.g. status dashboards
- Administer the provision of training to staff involved in survey activities
- Cross-check feedback received via surveys for complaint information and reconcile with product complaint reports on a continuing basis
Clinical Investigation Administration:
- Prepare communications with Ethic Committees for periodic updates or study updates
- Provide administrative support for provision of country/site specific training
- Manage database user change/addition requests
- Preparation of clinic documentation packs
- Manage newsletter creation and distribution process, including maintenance of address database, administration of design steps, etc
- General administrative tasks, i.e. filing and printing
Clinical Operations Administration:
- Coordinate investigation monitoring activities in close collaboration with Clinical Project Managers and (consultant) Clinical Research Associates
- Coordinate supplier finances in close collaboration with Clinical Project Managers: development of forecasts, tracking of actual costs and invoice management
- Coordinate document translation process
- Assists with the development of various processes and systems for streamlined clinical operations
- Ad hoc administrative tasks assigned by the Clinical Operations Manager
- Bachelor’s degree in one of health sciences, nursing, biomedical sciences, pharmacy, pharmacology, or a related discipline; or equivalent experience in clinical research.
- Understanding of the regulatory context, Good Clinical Practices (GCP), ISO 14155 and standard operating procedures.
- 2 years experience in Clinical Studies or related field
- Good communication skills – verbal and written.
- Evidence strong organizational/administrative skills – multiple tasks, multiple priorities and time management.
- Ability to build solid interpersonal relationship and to work independently.
- Detail oriented.
- English – Proficient written and spoken.
- Strong Microsoft Office skills: Word, PowerPoint and Excel.
- Ability to easily interact with online systems.
This is your chance to be part of a premier organization with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!
Cochlear’s mission is to help people hear and be heard. Around the world, more people chose 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 is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).
Cochlear is committed to providing equal opportunities to avoid unlawful discrimination on the grounds of race, sex, disability, sexual orientation, religion/belief or age.
In line with our corporate ethics and statutory obligations we strive to ensure that the work environment is free of harassment and bullying and that everyone is treated with dignity and respect - this is an important aspect of ensuring equal opportunities in employment.
Advertised: Romance Standard Time
Anticpated Application Closing: Romance Standard Time
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