Clinical Research Nurse

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

The Clinical Research nurse, Lombardi Cancer Center – Georgetown University, is a position in the benign Hematology clinical research program. Under the guidance and supervision of the Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Georgetown University policies and procedures.

This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. The clinical trial nurse also acts as study coordinator for research studies. Additional duties include but are not limited to:

• Ensures compliance with each study’s protocol.
• Participates in recruitment and selection of study participants.
• Provides patient education and medical information to study patients
• Supports the regulatory staff in the maintenance of regulatory documents
• Communicates and collaborates w/ study team including internal and external parties
• Develops accurate source materials

As an employee of Georgetown University, the Hematology Research program directly supports the University’s mission of cura personalis. Clinical Trials offer a unique opportunity for a patient to receive personalized and comprehensive care in a manner that they may not experience otherwise as a patient. Per the requirements of each clinical trial protocol, the research personnel are required to be the main point of contact for a patient in a clinical trial and must respond to inquiries from any patient within 24 hours.

The research nurse is instructed and required to maintain regular contact with each patient in their respective trials, because it is an FDA requirement to report adverse events in a timely manner, no matter the severity. As such, clinical trial patients develop close relationships with the research nurse for a trial, which provides unprecedented access to care when necessary. Operationally, the Research Nurse coordinates with other centers such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), the Research Pharmacy, the Radiology Center, Center of Medicine and Bone marrow transplant.

By interacting with other centers within the GUMC, the position indirectly supports research-related operations in centers ancillary to hematology. On a daily basis, the Research Nurse will report to the Center Administrator and Principal Investigator. The Research Nurse is part of a robust team comprised of 8 study team members (including the Research Nurse, the Administrator, 3 Principal Investigators, a Study Coordinator, Hemophilia Research Nurse and a Regulatory Coordinator).

The Research Nurse is responsible for managing at least 15 trials out of the overall portfolio of approximately 33 ongoing trials within our center. The portfolio consists of hematologic diseases, gene therapy and immunotherapy protocols. While the Research Nurse's primary direct report is to the Center Administrator, the Research Nurse will also provide project-specific deliverables to others such as, the PI for each trial, study team members, and to the sponsor contact (e.g., the study monitor appointed by the sponsor for each trial).

• Valid RN license
• Bachelor of Nursing degree
• Two (2) years of recent clinical nursing experience in a hospital, clinic or similar health care setting
• Nursing competency skills…