Clinical Research Associate | Hybrid
Listed on 2026-09-24
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Healthcare
Clinical Research
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At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.
Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,
Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.
Clinical Research Associate | Hybrid165196
Clinical Research AssociateJoin Advanced Bionics as aClinical 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.
ResponsibilitiesExecute 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 escalation study risks and ensure timely resolution of monitoring findings, data queries, protocol deviations, and safety-reporting requirements.
Maintain accurate and inspection-ready clinical documentation, includingTMF/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 youBachelor's degree inLife Sciences, Nursing, Biomedical Engineering, or another related scientific discipline.
Minimum2 years of clinical research experience, including at least1 year of independent site monitoring.
Experience managing multiple clinical sites and working withCTMS, EDC, and eTMF systems.
Strong knowledge ofICH-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 300
Mb/sec download and 10
Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee…
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