Remote Clinical Research Quality Leader

Astera Cancer Care; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

OneOncology seeks a senior quality assurance professional to advance the network's quality management system and drive regulatory compliance across sites. You will lead CAPA, monitor KPIs, oversee vendor qualification, and prep sites for sponsor/CRO audits and inspections.

Collaboration with directors and cross-functional teams will be essential to achieve continuous improvement in clinical research quality.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• Experience supporting FDA inspections highly preferred.
• Professional certification in clinical research and/or quality assurance highly preferred.

Responsibilities

• Support the Director, Research Quality, in advancing the quality management system for the network.
• Monitor and report on network's KPIs that measure the health of the quality operations.
• Lead the CAPA program by overseeing documentation, investigations, resolution and effectiveness evaluation of quality issues and audit findings.
• Oversee vendor qualification by coordinating assessments, maintaining docs, evaluating risks, ensuring regulatory and quality expectations.
• Prepare sites for sponsor/CRO audits and regulatory inspections; review documentation and resolve gaps.
• Serve as a resource for quality teammates including auditors and QC specialists.
• Support KPIs to assess effectiveness of quality management systems and drive continuous improvement.
• Promote programs for quality control, audits, inspections, and assessments across sites.
• Provide strategic guidance on SOPs and procedural documents to ensure regulatory alignment.
• Act as SME on regulatory requirements and advise stakeholders on compliance implications.
• Contribute to training programs on QA, regulatory compliance and clinical research best practices.
• Other duties as assigned to improve lives of people with cancer.

Skills

GCP knowledge

FDA regulations

ICH guidelines

Quality assurance

Regulatory compliance

Audits

Training delivery

Cross-functional collaboration

MS Office

Education

Bachelor's degree in a relevant field

Advanced degree preferred

Tools

CTMS

EDC systems

Electronic regulatory binders

MS Office software

Job description

OneOncology seeks a senior quality assurance professional to advance the network's quality management system and drive regulatory compliance across sites. You will lead CAPA, monitor KPIs, oversee vendor qualification, and prep sites for sponsor/CRO audits and inspections.

Collaboration with directors and cross-functional teams will be essential to achieve continuous improvement in clinical research quality.