Remote Senior Clinical Research Associate – Medical Devices

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

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.