CTO, Training, Education, Quality Control Manager

Jobtailor; Washington (District of Columbia); On-site; USD 120,000 - 180,000; Full time

Job summary

Lombardi seeks an experienced leader to supervise the Quality Control Team and oversee the internal QC monitoring and CAPA processes across consortium sites. The role drives training, onboarding, and continuing education while ensuring FDA/GCP compliance and NCI CCSG expectations.

You’ll engage with leadership and investigators, report to the CTO Administrative Director, and shape a comprehensive cancer clinical research training and quality program across the organization.

Qualifications

• Bachelor’s degree in biological science, health science, or a health-related field.
• Six or more years of clinical trials experience, including at least 3 years in cancer clinical research operations.
• 2–3 years of project management or supervisory experience.
• Ability to perform light travel to consortium sites.
• SOCRA (CCRP) or ACRP (CCRC/CCRA) certification.
• In-depth knowledge of FDA, Human Subject Protection, GCP/ICH guidelines, and NCI CCSG reviewer expectations.
• Master’s degree in biological science, health science, or a health-related field preferred.

Responsibilities

• Supervise, guide, and direct the Quality Control Team.
• Direct the internal QC monitoring and auditing program.
• Analyze audit trends and oversee CAPA plans.
• Design and evaluate onboarding frameworks and competencies across sites.
• Develop and maintain guidance documents to ensure uniform research practices.
• Engage in performance management including hiring, training, and mentoring direct reports.
• Provide strategic oversight and delivery of cancer clinical research training and quality control.
• Ensure onboarding, training, ongoing quality monitoring, and continuing education.
• Support compliant clinical research across consortium sites.
• Interact with leadership, managers, investigators, sponsors, auditors, and inspectors.
• Report directly to the Lombardi CTO Administrative Director.

Skills

Leadership

Mentoring

Team Management

Excellent Communication

Presentation Skills

Education

Bachelor's degree in a biological/health-related field

Master's degree preferred

Tools

CTMS OnCore

EMR

Job description

• Supervise, guide, and direct the Lombardi CTO Quality Control Team
• Direct the internal Quality Control monitoring and auditing program
• Analyze audit trends and oversee Corrective and Preventive Action (CAPA) plans
• Design, implement, and evaluate onboarding frameworks, role-specific competencies, and continuing education curricula across consortium sites
• Develop and maintain Lombardi CTO Guidance Documents to ensure uniform research practices
• Engage in performance management, including hiring, training, mentoring, and developing direct reports
• Provide strategic oversight, design, implementation, and delivery of a comprehensive cancer clinical research training, education, and quality control program
• Ensure faculty and staff receive onboarding, role-specific training, ongoing quality monitoring, and continuing education
• Support safe, effective, audit-ready, and compliant clinical research across consortium sites
• Initiate and support progress toward organizational strategic goals
• Interact with leadership, functional area managers, team members, direct reports, cross-functional teams, investigators, institutional departments, sponsors, auditors, federal inspectors, and peer NCI-designated Cancer Centers
• Report directly to the Lombardi CTO Administrative Director

Requirements

• Bachelor’s degree in biological science, health science, or a health-related field
• Six (6) or more years of clinical trials experience, including a minimum of three (3) years in cancer clinical research operations
• At least two (2) to three (3) years of project management or supervisory experience
• Ability to perform light travel to consortium sites
• Knowledge and/or experience with NCI CCSG expectations preferred
• SOCRA (CCRP) or ACRP (CCRC/CCRA) professional certification
• Previous supervisory responsibility preferredIn-depth knowledge of FDA, Human Subject Protection, GCP/ICH guidelines, and NCI CCSG reviewer expectations
• Strong understanding of medical/oncology terminology, complex visit structures, CTMS (OnCore), EMR, and clinical trial workflows
• Expertise in competency-based learning, learning needs assessments, and translating audit findings into targeted training
• Strong leadership, mentoring, and team management capabilities
• Ability to assess compliance risks, manage competing priorities, track metrics, and deliver results within defined timelines
• Excellent verbal, written, and presentation skills
• Compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP
• Master’s degree in biological science, health science, or a health-related field preferred

Core Competencies

Demonstrates expertise in clinical research operations, particularly in cancer clinical trials, with a strong focus on quality control, compliance, and training program development. Proven ability to lead teams, manage projects, and ensure adherence to regulatory standards while fostering a culture of continuous improvement.

Highest-signal resume keywords

• Clinical Trials Experience
• Cancer Clinical Research Operations
• Project Management
• SOCRA (CCRP) Certification
• FDA Compliance Knowledge

Hard Skills

• Clinical Trial Workflows
• Competency-Based Learning
• Audit Trend Analysis
• Corrective and Preventive Action (CAPA)
• Onboarding Framework Design
• Quality Control Monitoring
• Performance Management
• Metrics Tracking
• NCI CCSG Expectations
• GCP/ICH Guidelines

Soft Skills

• Leadership
• Mentoring
• Team Management
• Excellent Communication Skills
• Presentation Skills

Certifications & Qualifications

• SOCRA (CCRP)
• ACRP (CCRC/CCRA)

Industry Keywords

• Human Subject Protection
• Patient Confidentiality/HIPAA
• Clinical Research Training
• Continuing Education
• Research Practices

Tools & Technologies

• CTMS (OnCore)
• EMR