Job Overview
The Research Data Coordinator 2 (DC 2) is responsible for data management for phase I‑III oncology clinical trials conducted at the Lombardi Comprehensive Cancer Center (LCCC).
Responsibilities
- Support all aspects of clinical research data management for clinical trials conducted in the LCCC Clinical Research Management Office (CRMO) including collection of data from source documents and completion of case report forms (CRFs/eCRFs) per sponsor requirements.
- Collect and analyze information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for assigned research protocols.
- Accurately capture data in eCRFs/CRFs adhering to contractual timelines and site SOPs, and ensure query resolution with proper oversight.
- Request, upload, and resolve imaging-related queries for radiological images as per study protocols.
- Collect and organize source documents in electronic and paper format according to site policies and maintain accuracy of data entered in the Clinical Trials Management System (CTMS).
- Schedule sponsor monitoring and study close‑out visits, and provide support during internal and external monitoring and auditing preparation.
- Communicate with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members to maintain protocol integrity.
- Assist in training new Research Data Coordinators and monitor data entry for new staff and protocols.
- Attend protocol‑related training and complete all required study training in a timely manner.
- Participate in site initiation visits, ensure compliance with departmental, institutional, and federal requirements, and maintain confidentiality standards including HIPAA regulations.
- Perform other duties as assigned.
Required Qualifications
- High School Diploma or GED.
- Three (3) to five (5) years of related experience.
- Ability to work independently and as part of a team.
- Strong attention to detail, reliability, and ability to prioritize competing responsibilities.
Work Interactions
- Clinical Research Manager, Principal Investigators, Physicians, Clinicians.
- Lombardi Clinical Trial Office members: Clinical Research Nurses, Coordinators, Data & Regulatory Coordinators, Laboratory Technicians.
- External clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff.
- Clinical trial sponsors, auditors, and study monitors.
Work Mode Designation
This position has been designated as Hybrid, requiring 3 days on site.
Compensation
The projected salary range is $18.40 - $27.33 per hour, determined by qualifications, experience, and business needs.
EEO Statement
Georgetown University 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, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any characteristic protected by law.