Principal Clinical Research AssociateLocation: Remote (60% Travel Required)
Company: VB Spine
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
