Senior Clinical Research Associate | REMOTE

Sonova Group; United States; Hybrid; USD 91,000 - 114,000; Full time

Benefits offered by this job

Medical coverage

401k plan with company match

Hearing aid discount

Job summary

Sonova in the United States is seeking a Senior Clinical Research Associate to lead global medical device clinical studies from start-up to close-out. You will monitor sites, ensure protocol adherence and collaborate with cross-functional teams to maintain quality and compliance.

The role requires 5+ years of experience, travel 30–50%, familiarity with CTMS, EDC and eTMF, and strong knowledge of ICH-GCP and FDA regulations. This position offers a hybrid work model and comprehensive benefits.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering or related field.
• Minimum 5 years of clinical research experience with at least 2 years of independent site monitoring.
• Experience with CTMS, EDC, and eTMF systems.
• Strong knowledge of ICH-GCP, ISO 14155, FDA regulations and data quality.

Responsibilities

• Lead global clinical studies from site start-up through close-out per protocols and regulatory requirements.
• Conduct SQV/SIV/IMV/COV visits for complex/high-priority studies.
• Activate sites, train investigators, manage device accountability and close-out planning.
• Monitor enrollment, protocol compliance, and data quality at investigative sites.
• Resolve monitoring findings and site-performance issues; escalate risks with solutions.

Skills

Clinical monitoring

Regulatory compliance

Study coordination

Travel 30-50%

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Tools

CTMS

EDC

eTMF

Job description

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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.

Remote, United States

Senior Clinical Research Associate | REMOTE

165812

Senior Clinical Research Associate

Join Advanced Bionics as a Senior Clinical Research Associate and take a lead role in the operational execution of global medical device clinical studies from study start-up through close-out. You will manage complex investigative sites, drive study quality and performance, identify and mitigate operational risks, and serve as an experienced clinical operations resource to study teams while helping advance innovative hearing healthcare technologies.

Responsibilities

Independently lead the operational execution of assigned global clinical studies from site start-up through close-out in accordance with study protocols, ICH-GCP, ISO 14155, FDA regulations, and applicable international regulatory requirements.

Conduct site qualification, initiation, interim monitoring, and close-out visits (SQV, SIV, IMV, and COV) for complex or high-priority studies.

Lead site activation, investigator training, study device accountability, close-out planning, and other activities required to achieve study milestones.

Serve as the primary operational lead for assigned investigative sites, monitoring enrollment, site performance, protocol compliance, and data quality while proactively identifying and mitigating risks.

Independently resolve complex monitoring findings, protocol deviations, data queries, and site-performance issues while escalating significant risks with recommended solutions.

Maintain inspection-ready TMF/eTMF and investigator site documentation, support audits and regulatory inspections, and promote consistent application of clinical quality standards.

Partner with Clinical Trial Management, Data Management, Biostatistics, Regulatory Affairs, Quality, Medical Affairs, and external vendors while mentoring CRAs and supporting clinical operations process improvements.

More about you

Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another related scientific discipline.

Minimum 5 years of clinical research experience, including at least 2 years 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.

Demonstrated ability to independently manage complex studies, multiple priorities, operational risks, and site-performance challenges.

Strong organizational, communication, problem-solving, and time-management skills.

Ability to travel approximately 30–50% 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 in Class III medical device clinical trials, global multicenter studies, FDA IDE/PMA or EU MDR clinical studies; experience mentoring junior CRAs or leading monitoring activities; and knowledge of Risk-Based Monitoring/RbQM.

A minimum of 300Mb/sec download and 10Mb/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 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

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: $91K - $114K 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.