Training, Education & Quality Control Manager – Lombardi CTO

About the role

The Lombardi Clinical Trials Office (CTO) at Georgetown University seeks a manager to lead its Training, Education, and Quality Control program. This senior position oversees onboarding, competency development, and continuous quality monitoring for cancer clinical research staff across the LCCC consortium.

Key responsibilities

• Supervise and direct the Lombardi CTO Quality Control Team.
• Lead internal quality monitoring, audit analysis, and corrective/preventive action plans.
• Design and evaluate onboarding frameworks, role‑specific competencies, and continuing education curricula.
• Develop and maintain uniform guidance documents for research practices across consortium sites.
• Manage performance processes, including hiring, training, mentoring, and development of direct reports.

Required profile

• In‑depth knowledge of regulatory and quality compliance (FDA, GCP/ICH, Human Subject Protection, NCI CCSG expectations).
• Strong understanding of oncology research operations, medical terminology, CTMS (OnCore), EMR, and trial workflows.
• Expertise in adult education, competency‑based learning, and translating audit findings into targeted training.
• Proven leadership, supervisory, analytical, and organizational abilities.
• Excellent communication and presentation skills for interaction with investigators, staff, and external partners.

Required skills

• CTMS (OnCore)
• Electronic Medical Record (EMR) systems
• GCP/ICH guidelines
• FDA regulatory compliance
• Regulatory compliance management