Remote Clinical Research Associate — Medical Device Trials

Sonova USA Inc.; California (MO); Remote; USD 79,000 - 99,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k with company match

PTO and holidays

Job summary

Sonova is seeking a Clinical Research Associate (Remote) to support global medical device clinical studies from start-up through close-out. The role requires coordination with investigative sites, cross-functional teams, and regulatory activities to ensure high-quality research and compliance.

The candidate should have a life sciences degree, 2+ years of clinical research experience (1+ year with site monitoring), and proficiency with CTMS/EDC/eTMF, with the ability to travel up to 50% as needed.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or related discipline.
• Minimum 2 years of clinical research experience, including at least 1 year 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.
• Strong organizational, communication, problem-solving, and time-management skills with the ability to independently manage multiple priorities.
• Fluent English communication skills, both written and spoken.
• Ability to travel approximately 30-50% to study sites, conferences, and other study-related activities.

Responsibilities

• Execute clinical studies from site start-up through study close-out in compliance with study protocols, ICH-GCP, ISO 14155, FDA regulations, and applicable regulatory requirements.
• Conduct site qualification, initiation, interim monitoring, and close-out visits (SQV, SIV, IMV, and COV).
• Support site activation, investigator training, study device accountability, and study close-out activities.
• Serve as the primary operational contact for assigned investigative sites and monitor site performance, enrollment, protocol compliance, and data quality.
• Identify and elevate study risks and ensure timely resolution of monitoring findings, data queries, protocol deviations, and safety-reporting requirements.
• Maintain accurate and inspection-ready clinical documentation, including TMF/eTMF and investigator site files, and support audits and regulatory inspections.
• Collaborate with Clinical Trial Management and cross-functional partners to support successful study execution and regulatory submissions.

Skills

Fluent English

Independent site monitoring

CTMS

EDC

eTMF

Communication skills

Time management

Education

Bachelor's degree in Life Sciences/Nursing/Biomedical Engineering

Master's degree (preferred)

ACRP-CRA/ACRP-CP/SOCRa CCRP certification (preferred)

Tools

CTMS

EDC

eTMF

Job description

Sonova is seeking a Clinical Research Associate (Remote) to support global medical device clinical studies from start-up through close-out. The role requires coordination with investigative sites, cross-functional teams, and regulatory activities to ensure high-quality research and compliance.

The candidate should have a life sciences degree, 2+ years of clinical research experience (1+ year with site monitoring), and proficiency with CTMS/EDC/eTMF, with the ability to travel up to 50% as needed.