Clinical Research Associate

Sonova
United States
Workplace: HybridFull timeUSD 79,000 - 99,000Function: Research & Scientific (R&D)Experience: 2+ yearsEducation: bachelorsSkills: ["Organizational skills","Communication skills","Problem-solving","Time management","Ability to independently manage priorities"]

Execute global medical device clinical studies from site start-up through close-out, ensuring compliance with study protocols, ICH-GCP, ISO 14155, and FDA requirements. Conduct site qualification, initiation, interim monitoring, and close-out visits while serving as the primary operational contact for assigned investigative sites. Maintain inspection-ready TMF/eTMF and site documentation, identify/escalate risks and deviations, and collaborate with Clinical Trial Management and cross-functional partners to support regulatory submissions.

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FursaFursa
Sonova
Sonova
2 days ago

Clinical Research Associate

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Last checked: 1 hour agoStatus: Live

Job Summary

Execute global medical device clinical studies from site start-up through close-out, ensuring compliance with study protocols, ICH-GCP, ISO 14155, and FDA requirements. Conduct site qualification, initiation, interim monitoring, and close-out visits while serving as the primary operational contact for assigned investigative sites. Maintain inspection-ready TMF/eTMF and site documentation, identify/escalate risks and deviations, and collaborate with Clinical Trial Management and cross-functional partners to support regulatory submissions.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: Research & Scientific (R&D)

Key Responsibilities

  • •Execute clinical studies from site start-up through study close-out in compliance with protocols, ICH-GCP, ISO 14155, and FDA 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 performance, enrollment, protocol compliance, and data quality.
  • •Maintain accurate, inspection-ready clinical documentation (TMF/eTMF and site files) and support audits and regulatory inspections.
Travel: High travel

Pay and Benefits

Salary: USD 79,000 - 99,000
Perks:Health InsuranceDentalVision401kLife InsuranceParental LeavePaid HolidaysPaid Leave

Key Requirements

  • •Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline.
  • •Minimum 2 years of clinical research experience, including at least 1 year 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.
  • •Fluent English communication skills, with strong organizational and time-management abilities.
Experience:2+ yearsMedical devicesGlobal clinical trialsClinical monitoring
Education:Bachelor's in Life Sciences, Nursing, Biomedical Engineering, or related scientific discipline
Skills:Organizational skillsCommunication skillsProblem-solvingTime managementAbility to independently manage priorities
Certifications:ACRP-CRAACRP-CPSOCRA CCRP
Languages:English
Tech Stack:CTMSEDCETMFTMFICH-GCPISO 14155FDA regulations

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