[Hiring] Senior Clinical Research Quality and Compliance Specialist @Research Triangle Institute

Role Description

RTI seeks a Senior Clinical Research Quality and Compliance Specialist to provide internal leadership and subject matter expertise for FDA-regulated clinical research, including clinical trials conducted under Investigational New Drug applications (INDs). This role will support clinical trial infrastructure and integrate quality and risk management into ongoing study and program operations, including:

• Protocol support
• Monitoring
• Governance
• Operational oversight
• Regulatory compliance
• Inspection readiness

The Specialist will establish, maintain, and continuously improve quality management, risk management, audit readiness, corrective and preventive action (CAPA), vendor and subcontractor oversight, and essential document review processes.

The position will primarily support complex FDA-regulated clinical research programs and may provide related quality, regulatory, and risk-management expertise across other RTI clinical, laboratory, and biomedical research activities as needs arise.

Qualifications

• Bachelor’s degree and at least 12 years of relevant experience, or a Master’s degree and at least 10 years of relevant experience, or a PhD and at least 6 years of relevant experience, or an equivalent combination of education and experience.
• Relevant experience should include substantial hands-on experience supporting, overseeing, managing quality for, or auditing FDA-regulated clinical research. Experience with clinical trials conducted under an IND is required.

Requirements

• Demonstrated expertise in FDA-regulated clinical research, including applicable FDA regulations, ICH GCP, sponsor/CRO responsibilities, clinical trial oversight, quality-management systems, participant protection, data integrity, and regulatory compliance.
• Experience supporting sponsors, CROs, coordinating centers, clinical research networks, sites, laboratories, vendors, subcontractors, or complex multi-site clinical trial programs.
• Experience integrating quality and risk management into clinical trial planning and operations, including protocol implementation, monitoring, governance, and operational oversight.
• Experience with risk-based quality management, FDA inspection readiness, GCP audits, CAPA management, and vendor/subcontractor quality oversight.
• Strong judgment, communication, and influencing skills, with the ability to identify and appropriately escalate quality or compliance concerns while partnering constructively with project and scientific teams.
• Ability to operate independently as a senior subject matter expert while collaborating effectively across multidisciplinary and matrixed teams.
• Ability to develop practical SOPs, templates, tools, trackers, dashboards, audit plans, CAPA documentation, and inspection-readiness materials for complex clinical research environments.
• Ability to translate regulatory and quality requirements into practical approaches that support effective research operations.

Benefits

• Competitive base salary
• Generous paid time off policy
• Merit-based annual increases
• Bonus opportunities
• Robust recognition program
• Competitive range of insurance plans (including health, dental, life, and short-term and long-term disability)
• Access to a retirement savings program such as a 401(k) plan
• Paid parental leave for all parents
• Financial assistance with adoption expenses or infertility treatments
• Financial reimbursement for education and developmental opportunities
• Employee assistance program
• Numerous other offerings to support a healthy work-life balance

Company Description

RTI is committed to rewarding individual and team achievement through a total rewards package that reflects our values and dedication to our employees.