CRA II

System One

📍 Exton, PA, United States

Full-time other-general

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 co...
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