Clinical Research Nurse 1

Georgetown University•Vinalhaven, ME

18d•$66,783 - $126,720•Onsite

About The Position

Serves as a Clinical Research Nurse 1 for oncology clinical trials conducted in the Lombardi Clinical Trials Office of Georgetown University’s Lombardi Comprehensive Cancer Center. The position coordinates assigned clinical trials throughout their lifecycle, supports participant recruitment and consent, conducts or coordinates study procedures and assessments, and helps maintain protocol integrity, patient safety, and regulatory compliance. The nurse provides clinical and administrative support to research staff; coordinates participant care, education, follow-up, and specimen collection; maintains accurate study documentation and clinical trial management system records; and collaborates with research, clinical, regulatory, finance, and data teams. The role also liaises with sponsors, auditors, hospital personnel, and review bodies, and participates in study start-up, monitoring visits, audits, training, and assigned meetings. Duties are performed in accordance with applicable laws, Georgetown University Medical Center policies and procedures, human-subject protection requirements, HIPAA, and Good Clinical Practice guidelines.

Requirements

Bachelor’s degree required.
BLS certification required.
Registered Nurse (RN) license in the District of Columbia required.
Three to five years of nursing experience in a hospital, clinic, or similar health care setting required.
Strong verbal and written communication skills.
Strong organizational skills and attention to detail.
Reliability and ability to prioritize competing responsibilities.

Nice To Haves

At least one year of clinical research experience preferred.
At least one year of oncology experience preferred.
Experience working in inpatient or intensive care unit settings.
Knowledge of clinical research, research processes, and Good Clinical Practice (GCP).

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 information for protocol screening and eligibility assessment.
Interface with study participants and obtain and document informed consent in accordance with protocols, institutional policies, and regulatory guidelines.
Coordinate or conduct study procedures and assessments while maintaining protocol integrity, patient safety, and Good Clinical Practice standards.
Assist with care coordination across outpatient, inpatient, and home settings, including phone triage, symptom management, and proactive participant communication.
Document study activity and medical data in the participant’s medical record and, when applicable, research chart, according to 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 help ensure site compliance and appropriate research methods, practices, and procedures.
Coordinate research specimen collection 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 relevant staff on assigned clinical trials.
Update the Clinical Trials Management System with patient information and key dates to support 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 alleviate them.
Participate in assigned meetings, task forces, and committees.
Perform other duties as assigned and comply with applicable laws, regulations, institutional policies, SOPs, human-subject protection, patient confidentiality/HIPAA, and GCP.