Remote Senior Clinical Research Associate – Global Trials

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

Benefits offered by this job

Health insurance

401(k) plan with company match

Life/AD&D insurance

Disability coverage

Paid time off and holidays

Parental bonding leave

Employee assistance program

Job summary

Sonova is seeking a Senior Clinical Research Associate for a remote role in the United States. You will lead global clinical studies from site start-up to close-out, ensuring quality and compliance across sites.

You’ll work with CTMS, EDC, and eTMF, while mentoring CRAs and coordinating with cross-functional teams. Minimum 5 years in clinical research, including 2 years of independent site monitoring, and a strong background in ICH-GCP, ISO 14155, and FDA regulations.

Qualifications

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

Responsibilities

• Lead the operational execution of global clinical studies from site start-up through close-out per protocols, ICH-GCP, ISO 14155 and applicable regulatory requirements.
• Conduct site qualification, initiation, interim monitoring, and close-out visits for complex or high-priority studies.
• Lead site activation, investigator training, device accountability, close-out planning, and milestone achievement.
• Act as primary operational lead for investigative sites, monitor enrollment, protocol adherence, data quality, and site performance.
• Resolve monitoring findings, deviations, data queries, and site-performance issues; escalate risks with solutions.
• Maintain inspection-ready TMF/eTMF documentation and support audits/regulatory inspections.

Skills

Site monitoring

CTMS

EDC

eTMF

ICH-GCP

FDA regulations

ISO 14155

Data quality

Travel ready

Project management

Education

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

Tools

CTMS

EDC

eTMF

Job description

Sonova is seeking a Senior Clinical Research Associate for a remote role in the United States. You will lead global clinical studies from site start-up to close-out, ensuring quality and compliance across sites.

You’ll work with CTMS, EDC, and eTMF, while mentoring CRAs and coordinating with cross-functional teams. Minimum 5 years in clinical research, including 2 years of independent site monitoring, and a strong background in ICH-GCP, ISO 14155, and FDA regulations.