Clinical Research Nurse Coordinator I

Georgetown University•Vinalhaven, ME

12d•$54,616 - $100,493•Onsite

About The Position

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.

Requirements

Bachelor of Science in Nursing with active nursing license required
Two (2) to Seven (7) years of recent clinical nursing experience in a hospital, clinic, or similar health care setting
Nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG, EKG, administering injections, etc.)
At least one (1) year clinical trials research experience
Knowledge of medical terminology, drug calculation skills, clinical medicine, clinical trials and GCP concepts
Detail oriented and meticulous in all aspects of work
Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
Must have professional demeanor, strong communication skills with the public as well as physicians and co-workers
Ability to work well independently as well as in team environment
Strong interpersonal, customer service and multi-tasking skills are critical
Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire
Possess the ability to work well under pressure, multi-task, and manage deadlines
Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures

Responsibilities

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.