Research Data Coordinator 1
Job Overview
The Research Data Coordinator 1 position is responsible for data management for phase I, II, and III oncology clinical trials conducted within the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC). This position performs all duties in accordance with all applicable laws and regulations, adhering to Georgetown University Medical Center’s philosophies, policies, and SOPs, and complying with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice.
Responsibilities
* Support all aspects of clinical research data management for trials conducted in the LCCC Clinical Research Management Office (CRMO), including collection of data from source documents and medical records and completion of case report forms per sponsor requirements.
* Handle trials of varying complexity and disease indication.
* Work collaboratively with trial stakeholders and internal study teams (physicians, Regulatory team, Study Coordinators, nursing staff, Research Laboratory Technicians, and Research Pharmacy team).
* Review and analyze information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols including industry, national, and investigator‑initiated studies.
* Accurately capture data in electronic or paper Case Report Forms (eCRFs/CRFs) adhering to contractual timelines and site Standard Operating Procedures (SOPs).
* Ensure query resolution with proper physician and clinical study team oversight within site- and sponsor‑specific time requirements.
* Request and upload radiological images into sponsor-provided imaging platforms according to each study protocol.
* Resolve imaging-related queries with the assistance of the clinical study team.
* Collect and organize source documents in electronic and paper format according to site policies.
* Ensure accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates, and interface with study team members to resolve discrepancies.
* Schedule sponsor monitoring and study close‑out visits.
* Provide support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective action plans post‑audit.
* Communicate appropriately with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members.
* Collaborate closely with physicians and Study Coordinators to maintain protocol integrity.
* Attend protocol‑related training and complete all required study training in the required timeframe.
* Prepare for and participate in site initiation visits.
* Assure ongoing compliance with all departmental, institutional, and federal requirements and regulations, and maintain controls to assure accuracy, completeness, and confidentiality of research data.
* Maintain confidentiality standards for all potential and enrolled study participants; comply with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
* Other duties as assigned.
Work Interactions
* Clinical Research Manager
* Disease Group members: Principal Investigators, Physicians, Clinicians
* Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians
* External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff
* Clinical trial sponsors, auditors, and study monitors
Requirements and Qualifications
* High School Diploma or GED required.
* Up to two (2) years of related experience required.
* Strong candidates exhibit: Ability to work independently and function within a team.
* Strong attention to detail.
* Reliable and able to prioritize competing responsibilities.
Work Mode Designation
Hybrid 3 Days
Pay Range
$17.95 - $26.84 per hour
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.
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, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.
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