Research Data Coordinator I

Vor 6 Tagen

Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Georgetown University in Qatar Vollzeit
Job Summary

We are seeking a highly skilled Research Data Coordinator I to join our team at Georgetown University in Qatar. The successful candidate will be responsible for managing clinical research data for phase I, II, and III oncology clinical trials conducted in our Lombardi Comprehensive Cancer Center.

Key Responsibilities
  • Collect and manage clinical research data from source documents and medical records, ensuring accuracy and completeness.
  • Administer trials of varying complexity and disease indication, working collaboratively with trial stakeholders and internal study teams.
  • Review and analyze information from medical records to extract data for all assigned research protocols.
  • 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 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.
  • 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 actions plans post-audit.
  • Communicate effectively 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.
  • Maintain controls to assure accuracy, completeness, and confidentiality of research data.
  • Maintain confidentiality standards for all potential and enrolled study participants, and comply with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
Requirements and Qualifications
  • High School diploma or certified equivalency.
  • Up to 2 years of related experience.
  • Strong candidates exhibit ability to work independently and function within a team, strong attention to detail, reliability, and ability to prioritize competing responsibilities.
Work Interactions and Work Mode Designation
  • Clinical Research Manager.
  • Disease Group members: Principal Investigators, Physicians, Clinicians.
  • Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, Laboratory Technicians.
  • External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff.
  • Clinical trial sponsors, auditors, and study monitors.

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