CRA II

System One, Inc.; Darien (IL); Remote; USD 55,000 - 69,000; Full time

Job summary

System One, Inc. is seeking a CRA II for a 3-month contract. This remote position offers 40 hours per week and the chance to contribute to studies impacting patient outcomes in a fast-paced medical device setting.

The ideal candidate holds a Bachelor's Degree or RN, with 2+ years of monitoring, 3+ Clinical Research Coordinator experience, Class III device exposure, ICU/hospital site management, and must travel 2–4 times per month.

Qualifications

• Bachelor’s Degree or RN required.
• 2+ years monitoring experience.
• 3+ Clinical Research Coordinator experience.
• Class III Medical Device experience required.
• ICU/hospital/site management experience required.
• Ability to travel 2–4 times per month.

Responsibilities

• Maintain TMF and regulatory docs, ensure ICH/GCP/SOP compliance; oversee IRB approvals and AE reporting.
• Support study start-up and site readiness; manage supplies, queries, and corrective actions across studies.
• Facilitate team communications, milestones, audits, site payments, and SOP improvements.

Skills

Regulatory documentation

IRB approvals

Site management

Study start-up

Education

Bachelor's Degree or RN

Job description

Job Title: CRA II
Location: Remote, local to an airport
Type: 3 month Contract
Compensation: $40-$50/hr
Work Model: Remote
Hours: 40 hours/week
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.

Requirements

• 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 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.