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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 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.

The Quality Control Coordinator 1 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 Good Clinical Practice (GCP) guidelines.

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:

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:

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodations for any part of the application and hiring process, please visit the Office for Equal Opportunity Compliance website for general information about requesting accommodations, as well as information about requesting accommodations specifically for applicants. You also can also contact the Office for Equal Opportunity Compliance at (202) 687-4798 or oeoc@georgetown.edu.

Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.

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.