Clinical Research Associate
Sonova AG
Summary
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.
Job description
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.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another related scientific discipline
- Minimum 2 years of clinical research experience
- At least 1 year of independent site monitoring
- Experience managing multiple clinical sites
- Experience 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
- Fluent English communication skills, both written and spoken
- Ability to travel approximately 30–50%
Benefits
- Medical, Dental & Vision
- Health Savings Account
- Health Reimbursement Account
- Flexible Spending Account
- Dependent Care Account
- Telehealth Options
- 401(k) Matching
- Company Paid Life Insurance
- Company Paid AD&D Insurance
- Supplemental Life/AD&D Coverage
- Short-Term Disability
- Long-Term Disability
- STD/LTD Buy-ups
- Accident Insurance
- Hospital Indemnity Coverage
- Legal Assistance
- ID Theft Assistance
- PTO
- Floating Diversity Day
- Paid Holidays
- Paid Parental Bonding Leave
- Employee Assistance Program
- Career Growth Opportunities
- Tuition Reimbursement
- Hearing Aid Discount
- Social Recognition Platform
Company overview
Sonova Holding AG is a globally recognized Swiss medical device company specializing in innovative hearing care solutions. Founded in 1947 and headquartered in Stäfa, Switzerland, Sonova has established itself as one of the world's largest providers in the hearing care sector, holding approximately 24% of the global hearing aid market. The company operates through four core business divisions: Hearing Instruments, Audiological Care, Consumer Hearing, and Cochlear Implants. Sonova's diverse portfolio includes renowned brands such as Phonak, Unitron, Advanced Bionics, AudioNova, and licensed Sennheiser products. With over 17,990 employees worldwide, the company generates annual revenues exceeding CHF 3.6 billion and serves customers in more than 100 countries. Sonova's comprehensive offerings range from digital hearing aids and cochlear implants to wireless communication systems and professional audiological care services. As a component of the Swiss Market Index, Sonova maintains research facilities in Switzerland, Canada, and the United States, with manufacturing plants strategically located across Switzerland, China, and Vietnam. The company's mission centers on enabling people to experience the joy of hearing and live life without limitations through cutting-edge audio technology and comprehensive hearing care solutions.