Manager, Research Quality (Clinical Research)

Location: United States; remote

Company

hirify.global is a technology-powered oncology network supporting community oncologists, independent practices, and patients through a patient-centric, physician-driven model.

What you will do

• Advance the quality management system for the hirify.global Research Network.
• Monitor and report KPIs measuring the health and effectiveness of quality operations.
• Lead the CAPA program, including issue identification, investigation, resolution, and effectiveness evaluation.
• Oversee vendor qualification, assessments, documentation, and quality risk evaluation.
• Prepare network practices for sponsor and CRO audits and regulatory inspections.
• Develop and optimize SOPs, quality programs, training, audits, and compliance initiatives across research sites.

Requirements

• 4–8+ years of experience in clinical research quality assurance, regulatory compliance, training, and education.
• Bachelor’s degree required; an advanced degree in a relevant scientific discipline is preferred.
• In-depth knowledge of GCP, FDA regulations, ICH guidelines, and clinical trial quality assurance practices.
• Experience developing quality programs, conducting audits and inspections, and driving process improvements.
• Proficiency with Microsoft Office, electronic data capture systems, electronic regulatory binders, and clinical trial management systems.
• Ability to travel approximately 25% and maintain regular attendance.

Nice to have

• Experience supporting FDA inspections.
• Professional certification in clinical research or quality assurance.
• Advanced degree in a relevant scientific discipline.

Culture & Benefits

• Remote work arrangement for candidates based in the United States.
• Values-driven culture with startup enthusiasm and support from leaders in oncology, urology, technology, and finance.
• Opportunity to improve processes supporting independent physicians and patients living with cancer and other diseases.