Senior Clinical Research Associate | REMOTE (Valencia (CA), United States)

Sonova
United States
Workplace: RemoteFull timeUSD 100,000 - 125,000 annuallyFunction: Research & Scientific (R&D)Experience: 5+ yearsEducation: bachelorsSkills: ["Organizational skills","Communication skills","Problem-solving","Time management"]

Lead global medical device clinical studies end-to-end, from site start-up through close-out, ensuring protocol compliance and driving quality, performance, and risk mitigation. Conduct site qualification, initiation, monitoring, and close-out for complex studies; manage investigative sites and resolve findings, deviations, and data queries. Maintain inspection-ready TMF/eTMF documentation and partner across clinical trial management, data management, biostatistics, regulatory, and vendors while supporting CRAs.

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FursaFursa
Sonova
Sonova
15 hours ago

Senior Clinical Research Associate | REMOTE (Valencia (CA), United States)

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Last checked: 15 hours agoStatus: Live

Job Summary

Lead global medical device clinical studies end-to-end, from site start-up through close-out, ensuring protocol compliance and driving quality, performance, and risk mitigation. Conduct site qualification, initiation, monitoring, and close-out for complex studies; manage investigative sites and resolve findings, deviations, and data queries. Maintain inspection-ready TMF/eTMF documentation and partner across clinical trial management, data management, biostatistics, regulatory, and vendors while supporting CRAs.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: Research & Scientific (R&D)
Seniority: Mid level

Key Responsibilities

  • •Independently lead 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 requirements.
  • •Conduct site qualification, initiation, interim monitoring, and close-out visits for complex or high-priority studies.
  • •Lead site activation, investigator training, study device accountability, close-out planning, and milestone-related activities.
  • •Serve as primary operational lead for assigned investigative sites, monitoring enrollment, site performance, protocol compliance, and data quality while identifying and mitigating risks.
  • •Maintain inspection-ready TMF/eTMF and investigator documentation, support audits/inspections, and partner across clinical and vendor teams to improve clinical operations while mentoring CRAs.
Travel: High travel

Pay and Benefits

Salary: USD 100,000 - 125,000 annually
Perks:Health InsuranceDentalVision401kPaid Leave

Key Requirements

  • •Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline.
  • •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.
  • •Ability to independently manage complex studies, priorities, operational risks, and site-performance challenges.
Experience:5+ yearsMedical devicesClinical trialsGlobal studies
Education:Bachelor's
Skills:Organizational skillsCommunication skillsProblem-solvingTime management
Certifications:ACRP-CRAACRP-CPSOCRA CCRP
Tech Stack:ICH-GCPISO 14155FDA regulationsClinical monitoringSite managementCTMSEDCETMFTMFTMF/eTMFRisk-Based Monitoring (RbQM)ACR-CRA monitoring (implied)

Company Brief

Sonova
Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.
Industry: Medical Devices
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Stäfa, Switzerland
Founded: 1947
Website