Senior Clinical Research Associate

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At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

162384

Remote

Senior Clinical Research Associate

The Clinical Research Associate (CRA) supports the execution and oversight of feasibility, pivotal, and post-approval clinical investigations in accordance with FDA regulations, ISO 14155, ICH-GCP, and Sponsor standard operating procedures. The CRA is responsible for monitoring assigned investigational sites, ensuring protocol compliance, data integrity, and maintenance of inspection-ready documentation under the direction of the Senior Manager, Regulatory Clinical Research.

Responsibilities:

• Conduct qualification, initiation, interim monitoring, and close-out visits in accordance with the Monitoring Plan.
• Ensure investigational sites remain compliant with the approved protocol, regulatory requirements, and Sponsor SOPs.
• Perform source data review and verification to ensure accuracy, completeness, and traceability of clinical data.
• Review and ensure timely reporting of adverse events and device deficiencies.
• Support preparation of FDA Annual Reports and regulatory submissions as applicable.
• Maintain and reconcile TMF/eTMF documentation to ensure inspection readiness.
• Provide site training on investigational plan requirements and study procedures.
• Collaborate with Regulatory Affairs and Data Management to resolve data and compliance issues.
• Escalate protocol deviations, compliance concerns, or site performance issues as appropriate.
• Support internal and external audit readiness activities.

Travelling Requirement: Willingness to travel up to 45%, primarily in North America.

More about you:

• Bachelor’s degree in Life Sciences or a related field, or an equivalent combination of relevant clinical research experience (post-baccalaureate degree preferred).
• Minimum 7+ years of clinical research experience, including experience with Phase I–IV clinical trials and/or medical device studies.
• Experience supporting clinical monitoring activities in a Sponsor or CRO environment, including managing monitoring from site initiation through close-out.
• Working knowledge of ICH-GCP guidelines, FDA regulations, and applicable clinical research standards (e.g., 21 CFR Parts 50, 54, 56, 812 and ISO 14155).
• Experience supporting IDE submissions, PMA-related studies, FDA Annual Reports, and regulatory inspections or audits.
• Demonstrated ability to identify and manage site compliance risks, maintain regulatory documentation, and ensure protocol adherence.
• Strong organizational, documentation, and communication skills with the ability to manage multiple sites and tasks within a regulated, cross-functional clinical research environment.

A minimum of 200

Mb/sec download and 10

Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Don't meet all the criteria? If you’re willing to go allin and learn we'd love to hear from you!

We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier…