Inside Higher Ed · 1 week ago
Research Data Coordinator I
Washington, DC
Full-time
Hybrid
New Grad, Entry Level
$17.95/hr - $26.84/hr
0+ years expGeorgetown University is a prominent institution located in Washington, D.C., offering rigorous academic programs and a commitment to social justice. The Research Data Coordinator I position is responsible for data management for oncology clinical trials, collaborating with various stakeholders to ensure accurate data collection and compliance with research protocols.
PublishingEducationDigital MediaHuman ResourcesHigher EducationJournalismRecruiting
Responsibilities
Supports 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 medical records and completion of case report forms per sponsor requirements
Supports trials of varying complexity and disease indication
Works collaboratively with trial stakeholders and internal study teams (physicians, Regulatory team, Study Coordinators, nursing staff, Research Laboratory Technicians, and Research Pharmacy team)
Reviews and analyzes information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols - including but not limited to industry, national, and investigator-initiated studies
Accurately captures data in electronic or paper Case Report Forms (eCRFs/CRFs), adhering to contractual timelines and site Standard Operating Procedures (SOPs)
Ensures query resolution with proper physician and clinical study team oversight within site- and sponsor-specific time requirements
Requests and uploads radiological images into sponsor-provided imaging platforms according to each study protocol
Resolves imaging-related queries with the assistance of clinical study team
Collects and organizes source documents in electronic and paper format according to site policies
Ensures accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates
Interfaces with study team members to resolve discrepancies
Schedules sponsor monitoring and study close-out visits
Provides support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit
Communicates appropriately with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members
Collaborates closely with physicians and Study Coordinators to maintain protocol integrity
Attends protocol-related training and completes all required study training in the required timeframe
Prepares for - and participates in - site initiation visits
Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations
Maintains controls to assure accuracy, completeness, and confidentiality of research data
Maintains confidentiality standards for all potential and enrolled study participants; and complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations
Performs all duties in accordance with all applicable laws and regulations
Adheres to Georgetown University Medical Center's philosophies, policies, and SOPs
Works in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice
Other duties as assigned
Qualification
Required
High School Diploma or GED required
Up to two (2) years of related experience required
Ability to work independently and function within a team
Strong attention to detail
Reliable and able to prioritize competing responsibilities
Benefits
Medical
Dental
Vision
Disability and life insurance
Retirement savings
Tuition assistance
Work-life balance benefits
Employee discounts
An array of voluntary insurance options
Company
Inside Higher Ed
Inside Higher Ed is the online source for news, opinion, and jobs related to higher education.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-01-10Acquired
2006-08-31Series Unknown
Leadership Team
Stephanie Shweiki
Director, Foundation Partnerships
Recent News
Research & Development World
2025-05-03
Business Standard India
2025-04-11
Company data provided by crunchbase