Senior Clinical Research Associate (Data & Compliance)

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

A medical device company in Irvine, CA, is looking for a Senior Associate in Clinical Research. The role involves supporting clinical studies, ensuring regulatory compliance, and managing relationships with site coordinators and monitors. Candidates should have 2+ years of relevant experience, ideally in medical devices, and possess strong skills in clinical trial management, communication, and detail orientation. This position offers a dynamic work environment with a focus on technical and regulatory excellence.

Qualifications

• 2+ years of experience in clinical trial research, preferably in medical devices.
• Deep knowledge of GCPs governing clinical trials.

Responsibilities

• Support site management and interact with coordinators and monitors.
• Ensure quality data management activities, including data review and resolution.
• Conduct EDC training to external teams.
• Manage trial-related regulatory documents and maintain Trial Master Files.
• Support clinical audits and inspections during preparation.

Skills

Clinical trial management

Electronic data capture systems

Excellent communication skills

Attention to detail

Team player

Education

Advanced degree in biological science / pharmacy / nursing

Job description

A medical device company in Irvine, CA, is looking for a Senior Associate in Clinical Research. The role involves supporting clinical studies, ensuring regulatory compliance, and managing relationships with site coordinators and monitors. Candidates should have 2+ years of relevant experience, ideally in medical devices, and possess strong skills in clinical trial management, communication, and detail orientation. This position offers a dynamic work environment with a focus on technical and regulatory excellence.