Clinical Research Associate

Sonova AG • Santa Clarita, CA

9d • $79,000 - $99,000 • Hybrid

About The Position

Join Advanced Bionics as a Clinical Research Associate and help support the successful execution of global medical device clinical studies from study start-up through close-out. In this role, you will work closely with investigative sites and cross-functional teams to support high-quality clinical research, maintain regulatory compliance, and contribute to studies that support innovative hearing healthcare technologies.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another related scientific 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.
• A minimum of 300Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.

Nice To Haves

• Master's degree or equivalent
• ACRP-CRA, ACRP-CP, or SOCRA CCRP certification
• Experience with Class III medical device clinical trials
• Experience with global multicenter studies
• Experience with FDA IDE/PMA or EU MDR clinical studies
• Knowledge of Risk-Based Monitoring/RbQM

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 escalate 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.

Benefits

• Medical, dental and vision coverage
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match
• Company paid life/ad&d insurance
• Additional supplemental life/ad&d coverage available
• Company paid Short/Long-Term Disability coverage (STD/LTD)
• STD/LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Robust Internal Career Growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level