Senior Clinical Research Associate

Sonova
United States
Workplace: HybridFull timeUSD 100,000 - 125,000 annuallyFunction: Research & Scientific (R&D)Education: bachelorsSkills: ["Organizational skills","Communication skills","Problem-solving","Time management","Risk mitigation"]

Lead operational execution of global medical device clinical studies from start-up through close-out, ensuring adherence to study protocols, ICH-GCP, ISO 14155, and FDA/international regulations. Manage complex investigative sites via qualification, initiation, interim monitoring, and close-out activities, driving enrollment, site performance, protocol compliance, and data quality. Resolve complex findings and deviations, maintain inspection-ready TMF/eTMF documentation, and partner with cross-functional teams while mentoring CRAs and improving clinical operations processes.

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FursaFursa
Sonova
Sonova
2 days ago

Senior Clinical Research Associate

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Last checked: 44 minutes agoStatus: Live

Job Summary

Lead operational execution of global medical device clinical studies from start-up through close-out, ensuring adherence to study protocols, ICH-GCP, ISO 14155, and FDA/international regulations. Manage complex investigative sites via qualification, initiation, interim monitoring, and close-out activities, driving enrollment, site performance, protocol compliance, and data quality. Resolve complex findings and deviations, maintain inspection-ready TMF/eTMF documentation, and partner with cross-functional teams while mentoring CRAs and improving clinical operations processes.
Location: United States
Workplace: Hybrid
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 international regulatory requirements.
  • •Conduct site qualification, initiation, interim monitoring, and close-out visits (SQV, SIV, IMV, COV) for complex or high-priority studies.
  • •Lead site activation, investigator training, study device accountability, close-out planning, and activities needed to achieve study milestones.
  • •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 site documentation, support audits and regulatory inspections, and partner with cross-functional teams while mentoring CRAs.
Travel: High travel

Pay and Benefits

Salary: USD 100,000 - 125,000 annually
Perks:Health InsuranceDentalVision401kLife InsuranceStd/ltdPaid LeavePaid HolidaysParental Bonding

Key Requirements

  • •Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a 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.
  • •Ability to independently manage complex studies, multiple priorities, operational risks, and site-performance challenges.
Experience:Clinical researchMedical devicesGlobal multicenterFDA IDEEU MDR
Education:Bachelor's in Life Sciences, Nursing, Biomedical Engineering
Skills:Organizational skillsCommunication skillsProblem-solvingTime managementRisk mitigation
Certifications:ACRP-CRAACRP-CPSOCRA CCRP
Tech Stack:CTMSEDCETMFTMF

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