Senior Clinical Research Associate | REMOTE (Valencia (CA), United States)
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Job Description
Senior Clinical Research Associate Valencia, California – REMOTE FOR THE RIGHT CANDIDATE Join 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.
Responsibilities
Independently 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 you Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another related scientific discip
Required Skills
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