Clinical Research Coordinator, Center for Translational Transplant Medicine - Georgetown University
Clinical Research Coordinator, Center for Translational Transplant Medicine - Georgetown University Medical Center
Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center whose missions of research, teaching and patient care are carried out with a strong emphasis on community outreach and the Jesuit principle of cura personalis - care of the whole person. GUMC consists of the School of Medicine, the School of Nursing & Health Studies, Georgetown Lombardi Comprehensive Cancer Center, and Biomedical Graduate Research and Education.
The Clinical Research Coordinator is responsible for coordinating clinical trials in human subjects within the Center for Translational Transplant Medicine, ensuring that all protocol requirements and regulations for human subject's research are met. Reporting to the Research Operations administrator and Principal Investigators, the Coordinator has duties that include but are not limited to:
- Submits regulatory documents to sponsors and prepare and maintain protocol submissions with the IRB.
- Reviews protocol logistics and meet with relevant hospital departments and staff to conduct training and in-services for protocol procedures.
- Ensures adherence to all IRB, HHS, FDA, and OHRP regulations governing investigational drugs and human subjects.
- Manages patient screening, informed consent, enrollment, randomization, patient tracking, follow-ups, and data collection.
- Assists investigators in monitoring research subjects for adverse events, tracking concomitant medications, and all applicable device and drug regulations.
- Ensures accurate research data abstraction from medical records and EMR, adherence to departmental and hospital policies and procedures, and full compliance with research regulations for all trials assigned.
- Provides timely, consistent, error-free written and verbal communications that meet departmental standards.
- Bachelor's degree in science related field or Registered Nurse
- 1 year of experience in clinical research in human subjects
- Familiarity with clinical research and the research processes
- Excellent organizational, communications, and analytical skills, as well as attention to detail
- Ability for self-direction and to work independently
- Adaptability in unpredictable situations in the patient care setting
- Proficiency in MS Office applications, including word processing, spreadsheets, and database use
- Hospital-based drug and device research experience
- BLS certification
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