Clinical Research Associate

Sonova USA, Inc.; Valencia (CA); On-site; USD 72,000 - 90,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

PTO and holidays

Tuition reimbursement

Hearing aid discount

Job summary

Sonova USA, Inc. is seeking a Clinical Research Associate in Valencia, California to oversee global medical device clinical studies from start-up to close-out.

You will collaborate with investigative sites and cross-functional teams to ensure regulatory compliance and high-quality research that supports hearing healthcare technologies. The ideal candidate has at least 2 years of clinical research experience, including independent site monitoring, and strong knowledge of ICH-GCP, ISO 14155, and

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another related scientific discipline.
• Minimum 2 years of clinical research experience, including at least 1 year of independent site monitoring.
• Experience managing multiple clinical sites and working with CTMS, EDC, and eTMF systems.
• Strong knowledge of ICH-GCP, ISO 14155, FDA regulations, clinical monitoring, site management, and data quality.

Responsibilities

• Execute clinical studies from site start-up through study close-out in compliance with study protocols, ICH-GCP, ISO 14155, FDA regulations, and applicable regulatory requirements.
• Conduct site qualification, initiation, interim monitoring, and close-out visits (SQV, SIV, IMV, and COV).
• Support site activation, investigator training, study device accountability, and study close-out activities.
• Serve as the primary operational contact for assigned investigative sites and monitor site performance, enrollment, protocol compliance, and data quality.
• Identify and escalate study risks and ensure timely resolution of monitoring findings, data queries, protocol deviations, and safety-reporting requirements.
• Maintain accurate and inspection-ready clinical documentation, including TMF/eTMF and investigator site files, and support audits and regulatory inspections.
• Collaborate with Clinical Trial Management and cross-functional partners to support successful study execution and regulatory submissions.

Skills

Communication

Organization

Problem solving

Time management

Fluent English

Travel 30-50%

CTMS

EDC

eTMF

Education

Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or related

Tools

CTMS

EDC

eTMF

Job description

$72,000 to $90,000 DEPENDING ON LOCATION AND EXPERIENCE.

How we work.

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration.

Who we are

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.

Clinical Research Associate

Valencia, California

Join Advanced Bionics as aClinical Research Associateand help support the successful execution of global medical device clinical studies from study start-up through close-out. In this role, you will work closely with investigative sites and cross-functional teams to support high-quality clinical research, maintain regulatory compliance, and contribute to studies that support innovative hearing healthcare technologies.

Responsibilities

• Execute clinical studies from site start-up through study close-out in compliance with study protocols,ICH-GCP, ISO 14155, FDA regulations, and applicable regulatory requirements.


• Conductsite qualification, initiation, interim monitoring, and close-out visits (SQV, SIV, IMV, and COV).


• Support site activation, investigator training, study device accountability, and study close-out activities.


• Serve as the primary operational contact for assigned investigative sites and monitor site performance, enrollment, protocol compliance, and data quality.


• Identify and escalation study risks and ensure timely resolution of monitoring findings, data queries, protocol deviations, and safety-reporting requirements.


• Maintain accurate and inspection-ready clinical documentation, includingTMF/eTMF and investigator site files, and support audits and regulatory inspections.


• Collaborate with Clinical Trial Management and cross-functional partners to support successful study execution and regulatory submissions.

More about you

• Bachelor's degree inLife Sciences, Nursing, Biomedical Engineering, or another related scientific discipline.


• Minimum2 years of clinical research experience, including at least1 year of independent site monitoring.


• Experience managing multiple clinical sites and working withCTMS, EDC, and eTMF systems.


• Strong knowledge ofICH-GCP, ISO 14155, FDA regulations, clinical monitoring, site management, and data quality.


• Strong organizational, communication, problem-solving, and time-management skills with the ability to independently manage multiple priorities.


• Fluent English communication skills, both written and spoken.


• Ability to travel approximately30-50%to study sites, conferences, and other study-related activities.

Preferred qualifications include:a Master's degree or equivalent; ACRP-CRA, ACRP-CP, or SOCRA CCRP certification; experience with Class III medical device clinical trials, global multicenter studies, FDA IDE/PMA or EU MDR clinical studies; and knowledge of Risk-Based Monitoring/RbQM.

A minimum of 300Mb/sec download and 10Mb/sec upload speed internet connectivityis required to support any remote/hybrid employee functionality at Sonova.

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

What we offer

• Medical, dental and vision coverage*


• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts


• TeleHealth options


• 401k plan with company match*


• Company paid life/ad&d insurance


• Additional supplemental life/ad&d coverage available


• Company paid Short/Long-Term Disability coverage (STD/LTD)


• STD/LTD Buy-ups available


• Accident/Hospital Indemnity coverage


• Legal/ID Theft Assistance


• PTO (or sick and vacation time), floating Diversity Day, & paid holidays*


• Paid parental bonding leave


• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)


• Robust Internal Career Growth opportunities


• Tuition reimbursement


• Hearing aid discount for employees and family


• Internal social recognition platform

*Plan rules/offerings dependent upon group Company/location.

This role's pay range is between: $72,000 to $90,000 DEPENDING ON LOCATION AND EXPERIENCE

How we work

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

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.

Recruitment Fraud Warning

We have become aware of fraudulent recruitment activities in which individuals falsely claim to represent Sonova or recruitment agencies acting on our behalf. These individuals may contact potential candidates by email, messaging services or other channels and may offer employment opportunities or recruitment-related services, such as CV preparation or review, in exchange for payment.

Sonova will never ask candidates to pay fees or make payments as part of our recruitment process. We also do not require candidates to purchase recruitment, CV preparation, training or similar services as a condition of applying for or obtaining employment with us.

Please exercise caution if you receive an unsolicited communication claiming to relate to a vacancy at Sonova, particularly if it requests payment, financial information or other sensitive personal information.

If you are uncertain whether a recruitment communication is genuine, please verify the vacancy through our official careers page or contact us through the contact details published on our website.

Sonova accepts no responsibility for fraudulent communications or transactions made by individuals or organisations falsely claiming to represent us.