Senior Clinical Research Associate | REMOTE

Sonova AG; Oregon; Hybrid; USD 91,000 - 114,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Health Savings, Health Reimbursement,F

401k plan with company match

Company paid life/ad&d insurance

Short/Long-Term Disability coverage

Paid time off, holidays, and parental/

Tuition reimbursement

Hearing aid discount for employees and

Job summary

Sonova AG, via Advanced Bionics, seeks a Senior Clinical Research Associate to lead global clinical studies from start-up to close-out. You will monitor complex sites, drive study quality, and mitigate operational risks while collaborating with cross-functional teams across regulatory, data management, and medical affairs.

The role requires 5+ years in clinical research, site monitoring, and travel 30-50%. Remote work is possible for the right candidate, with a West Coast preference.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or related field.
• Minimum 5 years of clinical research experience, including at least 2 years of independent site monitoring.
• Experience with CTMS, EDC and eTMF systems.
• Strong knowledge of ICH-GCP, ISO 14155 and FDA regulations.
• Ability to travel 30-50% to sites and events.

Responsibilities

• Lead global clinical studies from start-up to close-out per protocols and regulatory requirements.
• Conduct SQV/SIV/IMV/COV visits for complex or high-priority studies.
• Activate sites, train investigators, and manage device accountability and milestones.
• Serve as operational lead for sites, monitor enrollment, performance, and data quality.
• Resolve monitoring findings and protocol deviations; escalate significant risks with solutions.
• Maintain inspection-ready TMF/eTMF and support audits/regulatory inspections.
• Partner with cross-functional teams and mentor CRAs to improve operations.

Skills

Organizational skills

Communication

Problem-solving

Time management

Travel readiness

Education

Bachelor's degree in Life Sciences

Master's degree or equivalent

Tools

CTMS

EDC

eTMF

Job description

Senior Clinical Research Associate Valencia, California - REMOTE FOR THE RIGHT CANDIDATE | WEST COAST BASED PREFERRED

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

• 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;
• 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.

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: $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.