Clinical Research Nurse CoordInator I

Clinical Research Nurse Coordinator I

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 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.

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 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

Work Mode Designation

This position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff positions can be found on the Department of Human Resources website.

Pay Range:

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:

$54,616.00 - $100,493.33

Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.

EEO Statement:

GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.

Benefits:

Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.