Clinical Research Nurse I

Georgetown University

2d•$54,616 - $100,493•Onsite

About The Position

Serves as a Clinical Research Nurse I for oncology clinical trials in the Lombardi Clinical Trials Office of Georgetown University’s Lombardi Comprehensive Cancer Center. The nurse coordinates assigned clinical trials throughout their lifecycle, supporting participant recruitment, screening, informed consent, protocol procedures, assessments, follow-up, patient education, symptom management, and safety. The role also supports clinical and administrative nursing operations, regulatory compliance, research documentation, specimen collection, staff training, CTMS updates, query resolution, adverse-event reporting, and coordination with internal and external study stakeholders. All duties must comply with applicable laws and regulations, Georgetown University Medical Center policies and SOPs, human-subject protection requirements, patient confidentiality/HIPAA, and Good Clinical Practice (GCP). This is an on-campus position.

Requirements

Bachelor’s degree.
BLS certification.
RN license in the District of Columbia.
Three to five years of nursing experience in a hospital, clinic, or similar health care setting.
Knowledge of clinical research, research processes, and Good Clinical Practice (GCP).
Excellent verbal and written communication skills.
Excellent organizational skills and attention to detail.
Reliability and ability to prioritize competing responsibilities.

Nice To Haves

At least one year of clinical research experience.
At least one year of oncology experience.
Experience working in inpatient or Intensive Care Unit settings.

Responsibilities

Coordinate assigned clinical trials throughout the trial lifecycle.
Collaborate with investigators and senior study team members on participant recruitment and selection; document and collect data for protocol screening and eligibility determinations.
Interface with study participants and obtain and document informed consent in accordance with protocols, institutional policies, and regulatory guidelines.
Coordinate or conduct study-related procedures and assessments while maintaining protocol integrity and patient safety and following GCP guidelines.
Assist in assessment, management, and coordination across outpatient, inpatient, and home care, including triaging phone calls, managing symptoms, and proactively communicating with patients.
Document study-related activity and medical data in the participant’s medical record and, when applicable, the patient research chart, in accordance with protocol and sponsor requirements.
Conduct participant follow-up according to established standards and protocols.
Provide clinical and administrative nursing support to Clinical Research Coordinator and Clinical Research Nurse positions.
Review regulatory requirements and ensure site compliance with research protocols and appropriate methods, practices, and procedures.
Coordinate research specimen collection per protocol requirements with Clinical Research Coordinators.
Educate patients about clinical trial participation, treatment, potential side effects, and required testing.
Schedule or conduct in-service training for appropriate staff on assigned clinical trials.
Update the Clinical Trials Management System (CTMS) with patient information and key dates to support financial management of clinical trials, in collaboration with Clinical Research Coordinators.
Collaborate with Data Coordinators to ensure trial documentation is complete and accurate and assist with timely query resolution.
Document and report serious adverse events according to protocol and institutional policy.
Liaise with hospital staff, physicians, the IRB, review committees, the clinical research finance team, and auditors.
Liaise with sponsors during study start-up and participate in site initiation visits, monitoring visits, and audits.
Identify barriers to patient and physician participation in clinical trials and develop and implement methods to alleviate them.
Participate in meetings, task forces, and committees as assigned.
Perform other duties as assigned.
Perform duties in accordance with applicable laws and regulations and Georgetown University Medical Center philosophies, policies, and SOPs, including human-subject protection, HIPAA confidentiality, and GCP requirements.