Principal Clinical Research Associate

Principal Clinical Research Associate

Location: Remote (60% Travel Required)

Company: VB Spine

Looking for a career where your work truly matters? At VB Spine, you'll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We're the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Principal Clinical Research Associate in our Clinical Affairs function within the Spine division, you'll serve as the primary point of contact with clinical sites, monitor assigned clinical trials to ensure data integrity and regulatory compliance, and provide leadership to other CRAs to drive efficient, high-quality study delivery.

What You'll Do:

• Serve as the primary point of contact with site staff and manage assigned sites throughout all phases of clinical studies, including complex and high-risk sites
• Conduct site selection, site initiation, interim monitoring, and study closure visits and associated activities
• Monitor study conduct to ensure compliance with study requirements, protocols, Good Clinical Practice (GCP), and applicable regulations
• Administer protocol and related study training to assigned sites and create/maintain study training materials
• Evaluate the quality and integrity of study site practices
• Manage study progress by tracking regulatory submissions and approvals, enrollment, data completion, and resolution of data discrepancies
• Regularly review safety data with study management to ensure consistency and appropriate follow-up
• Create and maintain thorough documentation of site management activities, monitoring findings, and action plans
• Identify and effectively communicate complex clinical or operational issues and drive them to resolution
• Serve as a subject matter expert during audits and inspections, including FDA inspections and notified body audits
• Provide mentorship and functional guidance to less experienced CRAs to support efficient and effective study deliverables

What You Bring:

• Bachelor's degree or equivalent in a science or healthcare field
• At least 8 years of relevant clinical research experience specifically in monitoring
• Required experience in the Device or Pharmaceutical industry
• Experience as a Clinical Research Coordinator, Clinical Trial Coordinator, or Clinical Research Associate preferred
• Fundamental knowledge of GCPs, the clinical study development process, and logistics
• Demonstrated independence in performing all phases of site monitoring and site management activities
• Ability to incorporate ISO, FDA, and relevant guidelines into documentation
• CCRA Certification required
• Strong interpersonal, written and oral communication, organizational, and planning skills
• Proven ability to work effectively in a team-based environment

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high-performing Clinical Affairs team where your expertise in clinical monitoring will help ensure the integrity and success of clinical studies that support innovative spinal technologies and improve patient lives.

Compensation:

Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $160,000.00 - $170,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, certifications, and market conditions.

Benefits include:

• Comprehensive health, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO) and holidays
• Ongoing training and professional development opportunities
• Opportunity to grow within a fast-paced, dynamic company