Senior Clinical Trials CRA — Medical Devices Site Leader

Terumo Cardiovascular Group; Northern (KY); Hybrid; USD 92,000 - 127,000; Full time

Job summary

Terumo Medical Corporation in the United States seeks a Senior Clinical Research Associate to monitor multiple clinical trial sites and ensure data quality and regulatory compliance across studies. The role focuses on site management, data verification, and ensuring adherence to protocol and GCP standards.

You will train site staff, collect regulatory documents, track enrollment, and support continuous process improvements to enhance trial efficiency and patient safety.

Qualifications

• BS / BA or higher in a clinical or scientific area required; RN preferred.
• Minimum of 5 years experience independently monitoring clinical trials; medical device preferred.
• Experience with regulatory regulations and GCP compliance.

Responsibilities

• Monitor multiple clinical trial sites and studies.
• Ensure study data quality and adherence to protocol and regulations.
• Train sites, manage regulatory documents and enrollment tracking.
• Prepare and maintain monitoring plans, CRF and study manuals.

Skills

Regulatory regs

Clinical research ops

Interpersonal skills

Problem solving

Attention to detail

Organizational skills

Trial management systems

Education

BS / BA or higher in a clinical or scientific area

RN preferred

Tools

Trial management systems

Job description

Terumo Medical Corporation in the United States seeks a Senior Clinical Research Associate to monitor multiple clinical trial sites and ensure data quality and regulatory compliance across studies. The role focuses on site management, data verification, and ensuring adherence to protocol and GCP standards.

You will train site staff, collect regulatory documents, track enrollment, and support continuous process improvements to enhance trial efficiency and patient safety.