Clinical Research AssociateValencia, California
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.
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.
More about you- 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.
Preferred qualifications include: a Master's degree or equivalent; ACRP-CRA, ACRP-CP, or SOCRA CCRP certification; experience with Class III medical device clinical trials, global multicenter studies, FDA IDE/PMA or EU MDR clinical studies; and knowledge of Risk-Based Monitoring/RbQM.
A minimum of 300Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.
Don't meet all the criteria? If you're willing to go all in and learn we'd love to hear from you!
We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources.
What we offer- 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
*Plan rules/offerings dependent upon group Company/location.
This role's pay range is between: $72,000 to $90,000
DEPENDING ON LOCATION AND EXPERIENCE 
