Quality Control Coordinator 1

Georgetown University; United States; Hybrid; USD 44,000 - 73,000; Full time

Job summary

Georgetown University’s Lombardi Comprehensive Cancer Center seeks a Quality Control Coordinator 1 to support cancer clinical trials across CCSG sites. You will perform quality assessments, ensure data integrity, and assist with audits under the TEQC Manager.

A bachelor’s degree in a biological/health science is required; travel to consortium sites may be needed. Proficiency with OnCore CTMS, Microsoft Office, and Google Workspace is expected. Certification (SOCRA/ACRP) is preferred.

Qualifications

• Bachelor’s degree in a biological science, health science, or related field.
• Knowledge of FDA, GCP, ICH guidelines and regulatory standards.
• Experience with oncology clinical trials preferred.
• SOCRA/CCRP or ACRP/CCRA certification preferred.
• Ability to travel to consortium sites as needed.

Responsibilities

• Perform quality control assessments and risk-based centralized eligibility reviews for cancer trials.
• Conduct regular quality reviews in CTMS (OnCore) to assure data integrity and SOP compliance.
• Assist in quality monitoring and external audits across LCCC consortium sites.
• Collaborate with ORQA and TEQC Manager to review audit findings and trends.
• Maintain Lombardi CTO SOPs and Guidance Documents to support uniform practices.

Skills

Regulatory compliance

Oncology research operations

Quality assurance

Attention to detail

Time management

Communication skills

CTMS OnCore proficiency

Microsoft Office

Google Workspace

Education

Bachelors in biological/health sciences

Tools

CTMS OnCore

Microsoft Office

Google Workspace

Job description

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.

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 Training, Education, and Quality Control (TEQC) Manager, the Quality Control Coordinator 1 interfaces with clinical research faculty and staff in the execution and maintenance of a comprehensive cancer clinical research quality control program across LCCC’s NCI Cancer Center Support Grant (CCSG) consortium sites. This position works in close coordination with LCCC consortium clinical research teams as well as the leadership and staff within the Georgetown University Medical Center (GUMC) Office of Research Quality Assurance (ORQA). The Quality Control Coordinator 1 performs study- and staff-level quality assessments to verify adherence to Lombardi CTO Guidance Documents, joint GUMC and MedStar Health Standard Operating Procedures (SOPs), and applicable federal, state, and institutional regulatory standards. Through proactive quality monitoring and audit support activities, the Quality Control Coordinator 1 plays an essential role in evaluating protocol compliance, supporting staff competency, and promoting audit readiness across all LCCC cancer clinical research studies.

Key responsibilities include, but are not limited to:

• Performing quality control assessments and risk-based centralized eligibility reviews for select cancer clinical trials (e.g., NCTN).
• Conducting regular quality reviews within the Clinical Trials Management System (CTMS; OnCore) to assure data integrity and SOP compliance.
• Assisting in the coordination, preparation, conduct, and follow-up for internal quality monitoring and external audits across LCCC consortium sites.
• Collaborating with ORQA and the TEQC Manager to review audit findings and identify systemic trends to inform future training and educational initiatives.
• Assisting with the maintenance of Lombardi CTO Standard Operating Procedures and Guidance Documents to support uniform research practices.

Required Knowledge, Skills, and Abilities

• Regulatory & Quality Compliance: Working knowledge of regulations governing clinical research conduct (FDA, Human Subject Protection, Good Clinical Practice [GCP], and International Council for Harmonisation [ICH] guidelines).
• Oncology Research Operations: Foundational understanding of medical and clinical research terminology, protocol visit structures, and clinical trial workflows, preferably within oncology therapeutic research.
• Quality Assurance Principles: Understanding of quality control reviews, source document verification, centralized eligibility screening, and audit preparation processes.
• Attention to Detail & Analytical Skills: Proven ability to review clinical research records accurately, identify protocol discrepancies or compliance gaps, and document findings clearly.
• Organization & Time Management: Strong organizational and problem-solving skills, with the ability to prioritize competing tasks and deliver high-quality results within defined timelines.
• Communication & Interpersonal Skills: Strong verbal, written, and presentation skills to effectively communicate compliance feedback, collaborate with study teams, and maintain effective working relationships with supervisors, peers, and internal stakeholders.
• Technical Proficiency: Proficiency with technology applications, including Microsoft Office (Word, Excel, PowerPoint), Google Workspace, and Clinical Trial Management Systems (CTMS; OnCore)

Work Interactions

This position reports directly to the Lombardi CTO Training, Education, and Quality Control Manager. The Quality Control Coordinator 1 interacts regularly with:

• Lombardi CTO Leadership & Management: Administrative Director, TEQC Manager, and Lombardi CTO Functional Area Managers.
• Lombardi CTO TEQC Team Members: Quality Control Coordinator(s)
• Lombardi CTO Functional Teams: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians, and IIT Office staff.
• LCCC Consortium Teams: Principal Investigators, physicians, and clinical research personnel across GUMC and consortium sites.
• Institutional Departments & Staff: Georgetown Office of Research Quality Assurance (ORQA), Institutional Review Board (IRB), Clinical Trials Business Office, MedStar Health Research Institute (MHRI), and MedStar hospital staff (e.g., Infusion Nurses, Oncology Pharmacists).
• External Entities: Clinical trial sponsors, external monitors, and regulatory inspectors.

Requirements and Qualifications

• Required: Bachelor’s degree in a biological science, health science, or related field.
• Ability to perform light travel to consortium sites, as needed.
• Preferred: Up to two (2) years of clinical research experience, preferably in oncology clinical trials.
• Knowledge of or prior experience with NCI Cancer Center Support Grant (CCSG) guidelines and expectations.
• Society of Clinical Research Associates (SOCRA / CCRP) or Association of Clinical Research Professionals (ACRP / CCRC / CCRA) certification.

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: $44,022.00 - $73,406.80 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.

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.

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.

We’re a leading research university with a heart. Founded in the decade that the U.S. Constitution was signed, we’re the nation’s oldest Catholic and Jesuit university. Today we’re a forward-looking, diverse community devoted to social justice, restless inquiry and respect for each person’s individual needs and talents. Grounded in our Jesuit, Catholic identity, the Spirit of Georgetown undergirds everything we do. Watch this video to learn more. Learn how HR CARES for faculty and staff, nurturing an environment of mutual respect where imaginations flourish and ideas are realized to positively impact the world. 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.