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Who we are

You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.

We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.

If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.

Join Sonova. Create sense.

Valencia (CA), United States

Senior Clinical Research Associate

Covid Protocol:

 

Upholding the company values is extremely important to Sonova, we take the health and safety of our employees, patients, customers and their families very seriously. To that end, we have concluded that the best way to ensure the safety of these individuals is to mandate that all of our newly-hired employees be fully vaccinated for COVID-19. Therefore, when considering whether to apply for this position, please know that in order to become employed by Sonova (if otherwise eligible), you must provide satisfactory proof, such as a vaccine card or other documentation, that you are fully vaccinated for COVID-19. You will not be required to provide this proof unless and until you receive a formal job offer from Sonova. Please also know that Sonova will provide accommodations to qualified individuals who cannot receive the COVID-19 vaccination because of a sincerely held religious belief or due to a medical issue or pregnancy.

In a life without sound, our work provides meaning. As the world’s leading hearing care provider, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we – through our core brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova – develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

Sonova has more than 14,000 committed employees in over 100 countries, all of whom contribute to something greater than themselves – they transform lives. Join our mission and become part of our team! Apply now for the following position: Sr. Clinical Research Associate.

 

The Senior Clinical Research Associates help to develop and support feasibility and pivotal clinical trials, ensuring compliance with applicable regulations and Sponsor operating procedures. They collaborate with investigators and study staff at research centers across the United States while ensuring that clinical trials operate to plan.

 

Key Tasks and Responsibilities:

• Ability to effectively support single and multi-center clinical trials

• Sound knowledge of regulatory requirements for clinical trials

• Provide oversight of study centers from start-up to closure, ensuring consistency in the exchange of protocol-related information.

• Responsible for assuring and documenting regulatory compliance of study centers through site visits including qualification, initiation, interim monitoring and close-out visits. 

• Assist with the development of study-related documents e.g. informed consent forms, case report forms, site training materials, clinical reports, protocols, etc.

• Assist in the preparation of regulatory submissions (e.g. investigational device exemption applications, institutional review board initial/continuing review),

and responding to requests for additional information.

• Maintain paper and electronic Trial Master Files, as well as a Clinical Trial Management System, through the collection and evaluation of regulatory documents.

• Assist with the negotiation of clinical trial agreements, including clinical contract amendments and requesting payments according to each contract.

• Responsible for requesting, tracking and overseeing device supply at investigational sites.

• Assist in the maintenance of standard operating procedures and assuring compliance to written procedures of the clinical research department.

 

Up to 20% travel to study centers, professional conferences, and corporate events

 

Requirements:

Education:

  • A Bachelor’s degree in a medically related discipline is required. A post-baccalaureate degree is preferred. 

Experience:

  • Previous training in clinical research is required. Training in electronic data management is preferred. 
  • 5+ years of relevant experience is required. Experience with medical devices is preferred. 
  • A detailed understanding of clinical requirements for clinical trial conduct (FDA, ISO) is required.  Experience with EUMDR is preferred. 
  • Fluency in English is required. Expertise in standard MS Office Software is required. 

 

Our offer:

  • Exciting and challenging work environment
  • Comprehensive benefits package
  • Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!

 

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

We love to work with great people and strongly believe that a diverse team makes us better.  We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.

 

We thank all applicants in advance; however only individuals selected for an interview will be contacted.  All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Director, Human Resources.

Sonova is an equal opportunity employer

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.