Lombardi CTO Training, Education, and Quality Control Manager

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

Requirements

Job Overview

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.

Reporting directly to the Lombardi CTO Administrative Director, 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.

The TEQC Manager provides direct oversight and managerial leadership for the Lombardi CTO Quality Control Team. Charged with ensuring cancer clinical research faculty and staff receive appropriate onboarding, role-specific training, ongoing quality monitoring, and continuing education, this role is essential to maintaining safe, effective, audit-ready, and compliant clinical research across all consortium sites. 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.

Key responsibilities include, but are not limited to:

• 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.

Required Knowledge, Skills, and Abilities

In-depth knowledge and expertise in:

• Regulatory & Quality Compliance: Comprehensive understanding of regulations governing clinical research conduct (FDA, Human Subject Protection, GCP/ICH guidelines) and NCI CCSG reviewer expectations.
• Oncology Research Operations: Strong understanding of medical/oncology terminology, complex visit structures, CTMS (OnCore), EMR, and clinical trial workflows.
• 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.
• Analytical & Organizational Skills: Proven ability to assess compliance risks, manage competing priorities, track metrics, and deliver high-quality results within defined timelines.
• Communication & Presentation Skills: Excellent verbal, written, and presentation skills to effectively educate and interact with PIs, clinical staff, executive leadership, and consortium partners

The Lombardi CTO TEQC Manager is expected to perform all duties in accordance with applicable laws and regulations and adhere to Georgetown University Medical Center’s philosophies, policies, and SOPs, as well as work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP.

Work Interactions

This position reports directly to the Lombardi CTO Administrative Director. The TEQC Manager interacts regularly with:

• LCCC and Lombardi CTO Leadership: Administrative Director and Medical Director
• Lombardi CTO Functional Area Managers
• Lombardi CTO Team Members
• Direct reports, including Quality Control Coordinators
• Cross-functional colleagues within the Data, Regulatory, Investigator-Initiated Trials (IIT) Office, and Administrative/Clinical Research Support Unit Teams
• LCCC Disease Group Members: Principal Investigators, physicians, and clinicians across LCCC consortium sites.
• Institutional Departments and Staff: Institutional Review Board (IRB), Office of Research Quality Assurance (ORQA), Clinical Research Operations Office, MedStar Health Research Institute (MHRI), and MedStar Washington Hospital Center (MWHC) personnel.
• External Entities: Clinical trial sponsors, auditors, federal inspectors, and peer NCI-designated Cancer Centers

Requirements and Qualifications

• Required 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.

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

Work Mode Designation

This position has been designated as Hybrid. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation.

Pay Range:

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:

$66,783.00 - $126,720.23

Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors.

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Submission Guidelines:

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EEO Statement:

GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.

Benefits:

Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.