[Hiring] Internal Clinical Research Associate @Cordis

Role Description

The Internal Clinical Research Associate (iCRA) is responsible for day-to-day management and oversight of assigned global clinical trial sites for sponsor-led medical device studies. The role focuses on:

• Proactive site management
• Site performance oversight
• Follow-up compliance
• Data quality
• Inspection readiness
• Support of clinical trial execution in compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements

The individual acts as the primary operational contact for assigned sites and works closely with Clinical Study Managers, Data Management, Monitoring, and cross-functional teams to ensure timely and high-quality study execution.

Qualifications

• Must be based on the U.S. East Coast
• Minimum requirement of a Bachelor's degree in Life Sciences or related field
• Minimum 3-5 years of experience in the medical device sector, preferably in a CRO or Sponsor setting
• Experience in site management and oversight of global clinical trial sites is required
• Strong understanding of ICH-GCP guidelines and FDA regulatory requirements
• Experience supporting FDA-regulated IDE clinical trials is strongly preferred
• Experience with FDA BIMO inspections, audit preparation, or inspection readiness activities is highly desirable
• Experience in peripheral vascular clinical studies is preferred

Requirements

• Strong organizational and prioritization skills with the ability to manage multiple sites and competing timelines
• Excellent communication and relationship management skills
• Strong attention to detail and proactive problem-solving mindset
• Ability to independently drive site follow-up and operational issue resolution
• Ability to work cross-functionally and collaboratively across global teams
• Comfortable working across multiple time zones, including the US, Europe, and Asia
• Strong sense of accountability and ownership

Benefits

• The expected pre-tax pay rate for this position is $71,500 - $96,000 per year
• Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge, and location
• US work authorization is a precondition of employment
• The company will not consider candidates who require sponsorship for a work-authorized visa