Lombardi CTO Training, Education, and Quality Control Manager

Georgetown University

1d•$66,783 - $126,720•Hybrid

About The Position

The Lombardi Clinical Trials Office (CTO) is a shared institutional resource of the Lombardi Comprehensive Cancer Center (LCCC) at Georgetown University. It provides administrative and clinical operations support for cancer clinical trials conducted by Lombardi investigators. The Lombardi CTO Training, Education, and Quality Control (TEQC) Manager is responsible for the strategic oversight, design, implementation, and delivery of a comprehensive cancer clinical research training, education, and quality control program for faculty and staff across LCCC’s NCI Cancer Center Support Grant (CCSG) consortium sites. This role provides direct oversight and managerial leadership for the Lombardi CTO Quality Control Team, ensuring that cancer clinical research faculty and staff receive appropriate onboarding, role-specific training, ongoing quality monitoring, and continuing education. This position is essential to maintaining safe, effective, audit-ready, and compliant clinical research across all consortium sites. As a key leader within the Lombardi CTO, the TEQC Manager serves as a positive change agent to initiate and support progress toward achieving organizational strategic goals.

Requirements

In-depth knowledge and expertise in Regulatory & Quality Compliance: Comprehensive understanding of regulations governing clinical conduct (FDA, Human Subject Protection, GCP/ICH guidelines) and NCI CCSG reviewer expectations.
In-depth knowledge and expertise in Oncology Research Operations: Strong understanding of medical/oncology terminology, complex visit structures, CTMS (OnCore), EMR, and clinical trial workflows.
In-depth knowledge and expertise in Adult Education & Quality Control: Expertise in developing competency-based learning, conducting learning needs assessments, and translating audit findings into targeted training.
Comprehensive professional skill set including Leadership & Supervisory Skills: Strong leadership, mentoring, and team management capabilities to guide direct reports and foster cross-functional collaboration.
Comprehensive professional skill set including Analytical & Organizational Skills: Proven ability to assess compliance risks, manage competing priorities, track metrics, and deliver high-quality results within defined timelines.
Comprehensive professional skill set including Communication & Presentation Skills: Excellent verbal, written, and presentation skills to effectively educate and interact with PIs, clinical staff, executive leadership, and consortium partners.
Bachelor’s degree in biological science, health science, or a health-related field.
Six (6) or more years of clinical trials experience, which must include 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.

Nice To Haves

Master’s degree in biological science, health science, or a health-related field.
Knowledge and/or experience with NCI CCSG expectations.
SOCRA (CCRC) or ACRP (CCRC/CCRA) professional certification.
Previous supervisory responsibility.

Responsibilities

Supervising, guiding, and directing the Lombardi CTO Quality Control Team
Directing the internal Quality Control monitoring and auditing program, analyzing audit trends, and overseeing Corrective and Preventive Action (CAPA) plans
Designing, implementing, and evaluating onboarding frameworks, role-specific competencies, and continuing education curricula across consortium sites
Developing and maintaining the Lombardi CTO Guidance Documents to ensure uniform research practices across Lombardi CTO trials and LCCC consortium sites.
Actively engaging in performance management, including hiring, training, mentoring, and developing direct reports.