Clinical Research Associate | Remote (Valencia (CA), United States)

Sonova
United States
Workplace: RemoteFull timeUSD 79,000 - 99,000Function: Research & Scientific (R&D)Experience: 2+ yearsEducation: bachelorsSkills: ["Organizational skills","Communication skills","Problem-solving","Time management","Independent prioritization"]

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

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
Sonova
Sonova
15 hours ago

Clinical Research Associate | Remote (Valencia (CA), United States)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 15 hours agoStatus: Live

Job Summary

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

Key Responsibilities

  • •Execute clinical studies from site start-up through study close-out in compliance with study protocols and applicable regulatory 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.
  • •Monitor site performance, enrollment, protocol compliance, and data quality; identify and escalate risks and ensure timely resolution of findings, data queries, and protocol deviations.
  • •Maintain inspection-ready clinical documentation (TMF/eTMF and investigator site files) and support audits and regulatory inspections.
Travel: High travel

Pay and Benefits

Salary: USD 79,000 - 99,000
Perks:Health InsuranceDentalVision401kLife InsuranceStd/ltdPaid ParentalRemote Work

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 (written and spoken) and the ability to travel approximately 30–50% to study sites and related activities.
Experience:2+ years
Education:Bachelor's
Skills:Organizational skillsCommunication skillsProblem-solvingTime managementIndependent prioritization
Certifications:ACRP-CRAACRP-CPSOCRA CCRP
Languages:English
Tech Stack:ICH-GCPISO 14155FDA regulationsCTMSEDCETMFTMFRisk-Based MonitoringRbQM

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