Clinical Research Nurse 1

Georgetown University

18d•$66,783 - $126,720•Onsite

About The Position

Serves as Clinical Research Nurse 1 for oncology clinical trials conducted in the Lombardi Clinical Trials Office of the Lombardi Comprehensive Cancer Center at Georgetown University. The position is responsible for coordinating assigned clinical trials throughout their lifecycle while supporting participant recruitment, screening, consent, study procedures, data collection, follow-up, and patient safety. The nurse coordinates care across outpatient, inpatient, and home settings, provides patient education and symptom-management support, and documents trial activity in medical and research records in accordance with protocols, institutional policies, regulatory requirements, and Good Clinical Practice (GCP). The role supports research compliance and study operations by reviewing regulatory requirements, coordinating research specimen collection, training staff, maintaining patient information and key dates in the Clinical Trials Management System (CTMS), resolving data queries, and reporting serious adverse events. The nurse serves as a liaison among study teams, hospital and clinic staff, investigators, sponsors, auditors, and other stakeholders, and participates in study start-up, initiation visits, monitoring visits, audits, meetings, and committees. All duties must comply with applicable laws and regulations and Georgetown University Medical Center policies and procedures, including human-subject protection, patient confidentiality/HIPAA, and GCP.

Requirements

Bachelor’s degree.
BLS certification.
Registered Nurse (RN) license in the District of Columbia.
Three to five years of nursing experience in a hospital, clinic, or similar healthcare 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 screening data and determine compliance with eligibility requirements.
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 with assessment, management, and coordination of care across outpatient, inpatient, and home settings, including phone-call triage, symptom management, and proactive patient communication.
Document study-related activity and medical data in the participant’s medical record and, when applicable, research chart, in accordance with protocol and sponsor requirements.
Conduct participant follow-up in accordance with established standards and protocols.
Provide clinical and administrative nursing support to Clinical Research Coordinator and Clinical Research Nurse positions.
Review regulatory requirements to ensure site compliance and appropriate methods, practices, and procedures for research activities.
Coordinate collection of research specimens with Clinical Research Coordinators according to protocol requirements.
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.
Regularly update the CTMS with patient information and key dates to support clinical trial financial management, in coordination 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 ways to address them.
Participate in assigned meetings, task forces, and committees.
Perform other duties as assigned and comply with applicable laws, regulations, Georgetown University Medical Center policies and SOPs, human-subject protection requirements, HIPAA, and GCP.