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.
Requirements
Job Overview
The Clinical Research Nurse Coordinator I (CRNC I), Center for Translational Transplant Medicine – Georgetown University , is a position within the CTTM clinical research program operating in collaboration with physicians at the MedStar Georgetown Transplant Institute (MGTI). Under the guidance and supervision of the Assistant Research Manager, in partnership with Principal Investigators (PIs) and the Director of CTTM, this role ensures that clinical trials are conducted with the highest degree of integrity and quality in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, Good Clinical Practice (GCP) guidelines, and Georgetown University policies. The CRNC I is primarily responsible for executing protocol-required visit procedures, collecting and managing study data, and safeguarding the rights, health, safety, and welfare of research participants.
Operating within the licensed scope of registered nursing practice, the CRNC I assesses, plans, implements, and documents nursing care for potential and enrolled research participants from pre-screening through study closure. The CRNC I collaborates closely with PIs, clinical research staff, and multidisciplinary teams across MedStar Georgetown University Hospital to seamlessly integrate research procedures into clinical workflows. Responsible for an assigned portfolio of clinical trials, the CRNC I performs key clinical and administrative duties requiring a thorough understanding of study protocols, ICH GCP principles, ALCOA+ documentation standards and best practices in clinical trial coordination.
Additional duties include, but are not limited to:
Ensures compliance with each study’s protocol and performs protocol-specific clinical assessments, interventions, and procedures within the RN scope of practice.
Protects the rights, safety, and well-being of study participants by monitoring for adverse events, managing safety reporting, and serving as a patient advocate throughout the trial lifecycle.
Participates in recruitment and selection of study participants. Leads informed consent process.
Prepares, maintains, and manages source documents and Case Report Forms adhering strictly to ALCOA+ standards, ICH GCP guidelines, and trial timelines.
Assists regulatory teams with protocol submissions, safety amendments, audit preparations, and maintaining delegation logs and study binders.
Educates research participants, families, and clinical staff on study protocols, investigational products, treatment schedules, and potential side effects.
Work Interactions
The Clinical Research Nurse Coordinator I (CRNC I) works under the direct supervision of the Assistant Research Manager in partnership with the CTTM Director and conducts the studies under direct oversight of the Principal Investigators (PIs). This individual will interact directly with patients, research participants, and their families. They work within the multidisciplinary team of the healthcare system and the university medical center, including the clinical research office, sponsored programs office, research development services, respective grants managers, and serve as primary point of contact with sponsors, CROs, Investigational Pharmacy, and IRBs.
Requirements and Qualifications
Bachelor of Science in Nursing with active nursing license required
Two (2) to Seven (7) years of recent…