Senior Clinical Research Associate — Remote

Sonova USA, Inc.; United States; À distance; USD 91 000 - 114 000; Plein temps

Avantages offerts par ce poste

Medical/Dental/Vision coverage

401(k) matching

Paid time off and holidays

Hearing aid discount

Tuition reimbursement

Résumé du poste

Sonova USA, Inc. is seeking a Senior Clinical Research Associate to lead global medical device clinical studies from start-up to close-out. The role is remote for the right candidate, with 30-50% travel across sites and conferences.

You will manage complex sites, ensure protocol compliance, and uphold high data quality while partnering with multiple departments to improve clinical operations processes.

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.

Responsabilités

• Independently lead the operational execution of global clinical studies from site start-up through close-out.
• Conduct site qualification, initiation, interim monitoring, and close-out visits for complex studies.
• Lead site activation, investigator training, study device accountability, close-out planning.
• Serve as the primary operational lead for investigative sites, monitor enrollment, site performance, and data quality.
• Resolve monitoring findings, protocol deviations, data queries, and site-performance issues.
• Maintain inspection-ready TMF/eTMF and investigator site documentation; support audits and inspections.
• Collaborate with cross-functional teams and mentor CRAs.

Connaissances

Communication

Organizational skills

Time management

Problem solving

Travel readiness

Formation

Bachelor's degree in Life Sciences

Outils

CTMS

EDC

eTMF

Description du poste

Sonova USA, Inc. is seeking a Senior Clinical Research Associate to lead global medical device clinical studies from start-up to close-out. The role is remote for the right candidate, with 30-50% travel across sites and conferences.

You will manage complex sites, ensure protocol compliance, and uphold high data quality while partnering with multiple departments to improve clinical operations processes.