Clinical Research Associate

Sonova AG; California; Hybrid; USD 72,000 - 90,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401k with company match

Paid time off and holidays

Hearing aid discount for employees

Parental bonding leave

Employee Assistance Program

Job summary

Sonova is seeking a Clinical Research Associate to support global medical device clinical studies from start-up to close-out. You will work with investigative sites and cross-functional teams to ensure high-quality clinical research, regulatory compliance, and data integrity.

The role requires a Bachelor’s in Life Sciences or related field, 2+ years of clinical research experience, and willingness to travel 30–50%. Hybrid work model and comprehensive benefits are offered.

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.
• Ability to travel approximately 30–50% to study sites and related activities.

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 elevate 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

Fluent English

Organizational skills

Communication skills

Problem-solving

Time management

Travel readiness

Education

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

Tools

CTMS

EDC

eTMF

Job description

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

166380

Clinical Research Associate

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 elevate 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.

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

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

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

Hearing aid discount for employees and family

Internal social recognition platform

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.