Position: Clinical Research Associate II (CRA II)Location: U.S. (Remote with ~ 50% travel)Industry: Medical DeviceExperience Level: 2-5 YearsWe’re seeking a driven Clinical Research Associate II (CRA II) to join our Clinical Operations team. In this role, you’ll support the successful execution of clinical studies by ensuring high-quality site management, data integrity, regulatory compliance, and strong collaboration with field and in-house teams. This position contributes directly to the advancement of important clinical trials and plays a key role in maintaining study quality and operational excellence.What You’ll Do- Maintain the electronic Trial Master File (TMF) to ensure accuracy, completeness, and compliance with ICH/GCP and SOPs.- Develop and review regulatory documents to support study start-up and ensure site readiness for initiation.- Conduct study training for site personnel and verify proper adherence to protocols and regulations.- Ensure investigational device accountability, tracking, and security at clinical sites.- Review and ensure timely reporting of adverse events and protocol-required data.- Identify, communicate, and help implement corrective actions for protocol or compliance deviations.- Support query resolution and review Data Clarification Forms (DCFs).- Obtain and maintain IRB approvals (local and central).What You Bring- Bachelor’s degree (science or healthcare discipline preferred).- Minimum 5 years of clinical research coordinator experience with 1-2 years of clinical monitoring experience.- Strong understanding of ISO, GCP, ICH, FDA, and other applicable clinical research regulations.- Proficient in Microsoft Word, Excel, PowerPoint.Preferred Qualifications- Experience supporting device trials; ICU experience; familiarity with risk-based monitoring or eTMF systems.Apply: Send your resume and cover letter to HR@Lungpacer.com.