Senior Clinical Research Associate, Medical Devices Trials

Diality Inc.; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Diality Inc. seeks a Clinical Research Associate (CRA) to support Clinical Operations in planning, coordinating, and executing Diality clinical trials in compliance with FDA, ISO 14155, and ICH-GCP guidance.

The role combines site management and administrative trial support to ensure smooth study operations. You will collaborate with clinical sites, internal teams, and external partners to maintain data quality and study timelines, including TMF maintenance, regulatory submissions, and

Qualifications

• Bachelor's degree in life science or related field.
• 5+ years clinical research experience, preferably in medical devices.
• Familiarity with FDA, ISO 14155 and ICH-GCP regulations.

Responsibilities

• Assist with trial start-up, including regulatory submissions and site feasibility.
• Maintain and organize the Trial Master File (TMF) and essential documents.
• Track trial documentation (contracts, investigator agreements, disclosures, training).
• Monitor study progress and prepare status reports for stakeholders.
• Support site readiness, contract negotiations, and training for sites.
• Perform remote monitoring activities (SDV, data checks) and manage safety reporting.
• Develop study tools, training materials, and site binders.
• Coordinate investigator meetings, SIVs, and other study activities.
• Collaborate with regulatory/quality teams to ensure compliance.
• Prepare regular study updates and presentations.

Skills

Attention to detail

Organizational skills

Communication skills

CTMS

EDC systems

Independence

Education

Bachelor's degree in life science

5+ years clinical research experience

Experience with medical devices

Job description

Diality Inc. seeks a Clinical Research Associate (CRA) to support Clinical Operations in planning, coordinating, and executing Diality clinical trials in compliance with FDA, ISO 14155, and ICH-GCP guidance.

The role combines site management and administrative trial support to ensure smooth study operations. You will collaborate with clinical sites, internal teams, and external partners to maintain data quality and study timelines, including TMF maintenance, regulatory submissions, and