Research Data Coordinator 2

Georgetown University•Vinalhaven, ME

3d•$18 - $27•Hybrid

About The Position

The Research Data Coordinator 2 (DC 2) position is responsible for data management for phase I, II, and III oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center (LCCC). This role 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. The position handles trials of varying complexity and disease indication and requires collaboration with various trial stakeholders and internal study teams.

Requirements

High School Diploma or GED required.
Three (3) to five (5) 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.

Responsibilities

Supporting 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.
Working collaboratively with trial stakeholders and internal study teams (physicians, Regulatory team, Study Coordinators, nursing staff, Research Laboratory Technicians, and Research Pharmacy team).
Reviewing and analyzing 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 capturing data in electronic or paper Case Report Forms (eCRFs/CRFs) adhering to contractual timelines and site Standard Operating Procedures (SOPs).
Ensuring query resolution with proper physician and clinical study team oversight within site- and sponsor-specific time requirements.
Requesting and uploading radiological images into sponsor-provided imaging platforms according to each study protocol.
Resolving imaging-related queries with the assistance of clinical study team.
Collecting and organizing source documents in electronic and paper format according to site policies.
Ensuring accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates. Interfacing with study team members to resolve discrepancies.
Scheduling sponsor monitoring and study close-out visits.
Providing support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit.
Communicating appropriately with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members.
Collaborating closely with physicians and Study Coordinators to maintain protocol integrity.
Assisting with training of incoming Research Data Coordinators, including the use of electronic data capture systems, answering data entry questions, and monitoring data entry for new staff and new protocols.
Attending protocol-related training and completing all required study training in the required timeframe.
Preparing for and participating in site initiation visits.
Assuring ongoing compliance with all departmental, institutional, and federal requirements and regulations. Maintaining controls to assure accuracy, completeness, and confidentiality of research data.
Maintaining confidentiality standards for all potential and enrolled study participants; complying with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
Other duties as assigned.