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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 Data Team Manager, the Research Data Coordinator 1 is responsible for supporting comprehensive clinical research data management for Phase I, II, and III oncology clinical trials conducted through the Lombardi CTO. This position manages trial data across varying complexity and disease indications, collaborating closely with multidisciplinary research teams to support accurate data collection, case report form completion, and audit readiness.

The Research Data Coordinator 1 reviews and abstracts clinical information from electronic medical records, populates electronic and paper Case Report Forms (eCRFs/CRFs) within contractual and institutional deadlines, facilitates timely query resolution, and maintains data integrity in the Clinical Trials Management System (CTMS; OnCore). Additionally, this role coordinates radiological image uploads, coordinates monitoring visits, and supports audits.

Key responsibilities include, but are not limited to:

• Reviewing and analyzing medical records (e.g., clinic notes, pathology reports, radiology scans, lab results) to extract clinical data for industry, cooperative group (national), and investigator-initiated trials.
• Fulfilling all sponsor-required data management deliverables and trial components, including adherence to contractual data entry windows, completion of protocol-specific training, and coordination of sponsor monitoring visits, audits, and study close-out
• Accurately capturing clinical research data in electronic or paper Case Report Forms (eCRFs/CRFs) in strict adherence to protocol timelines and site Standard Operating Procedures (SOPs).
• Investigating and resolving data queries in collaboration with Principal Investigators, Study Coordinators, and clinical study teams.
• Requesting, de-identifying, and uploading digital radiological images into sponsor imaging platforms per study requirements.
• Maintaining data accuracy within the Clinical Trials Management System (CTMS; OnCore).
• Supporting internal quality monitoring, sponsor monitoring visits, and audits through record preparation and prompt resolution of data deficiencies

The Research Data 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 Foundational knowledge in:

• Medical Terminology: Basic understanding of oncology medical terminology, laboratory values, diagnostic pathology, and clinical visit documentation.
• Clinical Research Data Standards: Working knowledge of clinical research principles, Case Report Form (CRF/eCRF) completion, Electronic Data Capture (EDC) systems, and Good Clinical Practice (GCP) guidelines.
• Regulatory Compliance & Data Privacy: Knowledge of federal regulations governing human research, with a strong commitment to maintaining strict patient confidentiality under HIPAA regulations.
• Attention to Detail & Accuracy: Exceptional precision in reviewing medical records, abstracting complex clinical information, and verifying data entries across systems.
• Organization & Multitasking: Proven ability to manage large volumes of clinical trial data, prioritize competing sponsor deadlines, and deliver high-quality work within defined timelines.
• Communication & Collaboration: Strong verbal, written, and interpersonal communication skills to effectively collaborate with Research Data Coordinators, PIs, Clinical Research Coordinators, Clinical Research Nurses, and external study monitors.
• Technical Proficiency: Proficiency with technology applications, including Microsoft Office (Word, Excel, PowerPoint), Google Workspace, Electronic Medical Records (EMR), and Clinical Trial Management Systems (CTMS; OnCore).

Work Interactions

This position reports directly to the Lombardi CTO Data Team Manager. The Research Data Coordinator 1 interacts regularly with:

• Lombardi CTO Leadership & Management: Administrative Director, Data Team 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, Research Laboratory Technicians, Quality Control Coordinators, and IIT Office staff.
• Clinical & Disease Group Teams: Principal Investigators, treating physicians, clinical sub-investigators, oncology pharmacists, and infusion nursing staff.
• External Entities: Pharmaceutical trial sponsors, Contract Research Organizations (CROs), external clinical research associates (CRAs/monitors), and regulatory auditors.
  

Requirements and Qualifications

Required:

• High School Diploma or GED required.
• Up to two (2) years of related clinical research or medical record data entry experience required.
• Ability to work independently and function effectively within a multidisciplinary team.
• Strong attention to detail with proven organizational and time management skills.

Preferred:

• Bachelor’s degree in a biological science, health science, or related discipline.
• Prior experience with oncology clinical trials and electronic data capture (EDC) platforms (e.g., Medidata Rave, RedCap, Inform).
• Familiarity with OnCore or related Clinical Trials Management Systems (CTMS).

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.