Job Description

Job Title: CRA II
Location: Must be Mid-West based in the United States
Type: Direct Hire, full time permanent direct with the client
Salary Range: $82,000 - $107,000 commemorate with level of experience
Model: Hybrid – onsite and remote
Hours: 40.0


Looking for your next step as a CRA? This is an opportunity to join a fast-moving medical device organization where you'll have meaningful ownership, strong visibility within Clinical Operations, and the ability to contribute to studies that can directly impact patient outcomes.

Responsibilities

• Maintain TMF and regulatory documentation ensuring ICH/GCP and SOP compliance; oversee IRB approvals, informed consent quality, investigational device accountability, and complete/accurate reporting of AEs and protocol-required data.
• Support study start-up and site readiness, conduct site training, manage study supplies and tracking systems, resolve queries/DCFs, and identify/implement corrective actions for protocol deviations across multiple concurrent studies.
• Drive communication through team meetings, status reporting, and milestone tracking; support audits and site payments, lead documentation updates, and contribute to SOP enhancements and operational best practices.

• Bachelor’s Degree, or RN required
• 2+ years monitoring experience
• 3+ Clinical Research Coordinator experience
• Class III Medical Device experience required
• ICU (and therefore hospital) and site management experience required
• Ability to travel 2-4 times/month (depends on volume of need)

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical

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