Remote CRA II: Medical Device Trials (3-Month Contract)

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

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.