Senior Clinical Research Associate - Device Trials Lead

Terumo Cardiovascular Group; New Jersey; On-site; USD 92,000 - 127,000; Full time

Job summary

The Sr. CRA at Terumo Medical Corporation supports day-to-day operations of clinical trials, monitoring multiple sites to ensure data quality, adherence to protocol, GCP, and regulatory requirements.

Serving as the primary site liaison, you will train sites, collect regulatory documents, track enrollment, and verify CRFs against source data. You will help develop procedures and templates to support Terumo's continuous quality improvement while coordinating with investigators, CRA managers, and

Qualifications

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

Responsibilities

• Oversee investigator evaluation, site recruitment, and pre-visits to select qualified sites.
• Manage start-up activities: protocol/ICF/CRF guidance, monitoring plans, and regulatory documents.
• Conduct site visits, training, device handling, CRF collection, and data reconciliation.

Skills

Communication

Regulatory knowledge

Problem solving

Detail orientation

Project coordination

Education

BS/BA in clinical or scientific field

RN preferred

Tools

Clinical trial management systems

Job description

The Sr. CRA at Terumo Medical Corporation supports day-to-day operations of clinical trials, monitoring multiple sites to ensure data quality, adherence to protocol, GCP, and regulatory requirements.

Serving as the primary site liaison, you will train sites, collect regulatory documents, track enrollment, and verify CRFs against source data. You will help develop procedures and templates to support Terumo's continuous quality improvement while coordinating with investigators, CRA managers, and