Senior Clinical Research Associate - Remote Global Trials

Sonova USA Inc.; California; Remote; USD 100,000 - 125,000; 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 Senior Clinical Research Associate to lead global clinical studies from start-up to close-out, ensuring adherence to ICH-GCP, ISO 14155 and FDA regulations. The role requires managing multiple sites, training investigators, and maintaining TMF/eTMF while mitigating risks.

You will work in a remote-capable role with travel 30–50%, collaborating with cross-functional teams to drive study quality and timelines across global sites.

Qualifications

• 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.

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.

Skills

Clinical research

Independent site monitoring

Site management

Regulatory compliance

Travel readiness

Communication

Time management

Education

Bachelor’s degree in Life Sciences or related

Tools

CTMS

EDC

eTMF

Job description

Sonova USA Inc. is seeking a Senior Clinical Research Associate to lead global clinical studies from start-up to close-out, ensuring adherence to ICH-GCP, ISO 14155 and FDA regulations. The role requires managing multiple sites, training investigators, and maintaining TMF/eTMF while mitigating risks.

You will work in a remote-capable role with travel 30–50%, collaborating with cross-functional teams to drive study quality and timelines across global sites.