Senior Clinical Research Associate
Listed on 2026-08-27
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Healthcare
Clinical Research, Healthcare Compliance
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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.
Senior Clinical Research Associate165195
Senior Clinical Research AssociateJoin Advanced Bionics as a Senior Clinical Research Associate and take a lead role in the operational execution of global medical device clinical studies from study start‑up through close‑out. You will manage complex investigative sites, drive study quality and performance, identify and mitigate operational risks, and serve as an experienced clinical operations resource to study teams while helping advance innovative hearing healthcare technologies.
ResponsibilitiesIndependently lead the operational execution of assigned global clinical studies from site start‑up through close‑out in accordance with study protocols, ICH‑GCP, ISO 14155, FDA regulations, and applicable international regulatory requirements.
Conduct site qualification, initiation, interim monitoring, and close‑out visits (SQV, SIV, IMV, and COV) for complex or high‑priority studies.
Lead site activation, investigator training, study device accountability, close‑out planning, and other activities required to achieve study milestones.
Serve as the primary operational lead for assigned investigative sites, monitoring enrollment, site performance, protocol compliance, and data quality while proactively identifying and mitigating risks.
Independently resolve complex monitoring findings, protocol deviations, data queries, and site‑performance issues while escalating significant risks with recommended solutions.
Maintain inspection‑ready TMF/eTMF and investigator site documentation, support audits and regulatory inspections, and promote consistent application of clinical quality standards.
Partner with Clinical Trial Management, Data Management, Biostatistics, Regulatory Affairs, Quality, Medical Affairs, and external vendors while mentoring CRAs and supporting clinical operations process improvements.
More about youBachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another related scientific discipline.
Minimum 5 years of clinical research experience, including at least 2 years 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.
Demonstrated ability to independently manage complex studies, multiple priorities, operational risks, and site‑performance challenges.
Strong organizational, communication, problem‑solving, and time‑management skills.
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 in Class III medical device clinical trials, global multicenter studies, FDA IDE/PMA or EU MDR clinical studies; experience mentoring junior CRAs or leading monitoring activities; and knowledge of Risk‑Based Monitoring/RbQM.
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