Senior CRA: Impactful Trials & Global Growth

Premier Research Group; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Premier Research is seeking a Senior Clinical Research Associate / CRA II to join the Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas into new medicines, devices, and diagnostics.

We value growth, flexibility, and a voice that matters as we deliver medical innovation to patients. Join us to deliver high-quality monitoring reports, manage site visits, and maintain TMF/eTMF in compliance with ICH/GCP.

Qualifications

• Undergraduate degree in clinical, science, or health-related field, or equivalent work experience.

Responsibilities

• Delivers quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
• Maintains submission of expenses according to travel and expense requirements within company guidelines.
• Monitors (remote, onsite or other approved mode) with a focus on data integrity and patient safety per country regulations.
• Plans day-to-day activities for monitoring of a clinical study and sets priorities per site.
• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out visits.
• Maintains Trial Master File (TMF)/eTMF per filing guidelines and verifies essential documents per ICH/GCP.

Education

Undergraduate degree (clinical, science, or health-related field)

Licensed health-care professional

Job description

Premier Research is seeking a Senior Clinical Research Associate / CRA II to join the Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas into new medicines, devices, and diagnostics.

We value growth, flexibility, and a voice that matters as we deliver medical innovation to patients. Join us to deliver high-quality monitoring reports, manage site visits, and maintain TMF/eTMF in compliance with ICH/GCP.