Note: The job is a remote job and is open to candidates in USA. VB Spine is a medical technology company focused on innovation and improving patient outcomes in spine care. The Principal Clinical Research Associate serves as the primary contact for clinical sites, monitors assigned trials for data integrity and regulatory compliance, and mentors other clinical research associates to support high-quality study delivery.
Responsibilities
- 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
Skills
- 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
- 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
- Experience as a Clinical Research Coordinator, Clinical Trial Coordinator, or Clinical Research Associate preferred
Benefits
- Potential for bonuses and incentives
- 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
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