Job Description

Clinical Research Associate responsible for monitoring medical device clinical trials at the site level, ensuring subject safety, data accuracy, and regulatory compliance. Position supports trial initiation, enrollment, and closure activities across Boston, Philadelphia, or Dallas locations.

Responsibilities

• Review subject source documents and verify Case Report Form data against source documentation
• Identify, document, and escalate protocol deviations and data discrepancies to sponsor and sites
• Communicate study requirements and findings through monitoring reports, letters, and correspondence
• Monitor site personnel training records and ensure regulatory compliance during clinical trials
• Support regulatory inspection activities and event reporting as required by protocol

Requirements

• Minimum 1 year medical device clinical research experience
• Minimum 2 years site monitoring experience
• Bachelor's degree or registered nurse qualification
• Ability to travel up to 60%
• Therapeutic knowledge in interventional cardiology, cardiac rhythm management, neuromodulation, urology, or endoscopy
• Proficient with Microsoft Office applications
• Medidata RAVE and VEEVA Vault experience preferred

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