Clinical Research Associate / CRA I

at  Cochlear Ltd

Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear 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.
We are looking for a Clinical Research Associate (CRA I) to join our EMEA Clinical Operations team to work in a permanent, full-time capacity, linked to one of our European offices.
In this role you will be supporting the conduct of company sponsored clinical projects from the planning, execution to close-out phase and collaborate closely with the responsible Clinical Project Manager (CPM). Project types include company sponsored investigations, Controlled Market Releases (CMR) and Post-Market Clinical Follow-up (PMCF) projects. As CRA you facilitate administrative and data management tasks while assuring strict compliance to the procedures governing Clinical Affairs and Research in EMEA. This includes the setup and oversight of survey collection tools and generation of reports as required.

Key accountabilities include:

• Drive document filing, translation management, invoice processing as well as budget and timeline maintenance for assigned clinical investigations.
• In collaboration with external CROs and country teams facilitate smooth submission and reporting to Ethics Committees (EC).
• Conduct and document investigational site visits according to study specific Monitoring Plans and provide training and support to site staff.
• Support generation and maintenance of Investigational Site Files (ISF).
• Collaborate with Clinical Trial Compliance team to facilitate timely action to observations made during Quality Checks (QC).
• From time-to-time conduct User Acceptance Testing (UAT) of study specific Electronic Data Capture (EDC) setups.
• Develop and support data collection tools for CMR and PMCF activities on Cochlear’s online survey platforms.
• Manage survey data collected, create summaries and report feedback information into appropriate channels.
• For all activities supported, ensure compliance with Cochlear’s SOPs and applicable regulations, such as Good Clinical Practice (GCP, ISO14155) and EU General Data Protection Regulation (GDPR).
• Other duties as required.

You bring:

• Higher education level or BSc in life sciences or equivalent
• Ideally with accreditation/certification as Clinical Research Associate
• Proven experience in document oversight for clinical studies
• Qualified knowledge of clinical investigations regulations (GCP, GDPR), ideally including medical devices (ISO14155, EU MDR)
• Expertise in using online survey tools and Electronic Data Capture (EDC) systems and ideally electronic clinical trial systems (eTMF, CTMS)
• Solid expertise with common business software, such as MS Office applications
• Fluency of English language, particularly in written, plus full language proficiency a recruitment site
• Being a team player with the ability to work in a multi-disciplinary environment while having the ability to work independently with a sense of priority
• Ability to travel predominantly locally for 20-30% of time.
• Being excited by the prospect to help more people around the world to hear again and live full lives

What we offer
An attractive remuneration package and flexible extra-legal benefits
An extensive onboarding and training program
An enjoyable work environment with attention to life-work balance and homeworking
A stimulating environment with growth opportunities and opportunity to meet multi-disciplinary colleagues across the globe
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 Summary
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™).
Equal opportunities
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.

Please refer the Job description for details