Clinical Research Nurse 1

Georgetown University

7d•$54,616 - $100,493•Onsite

About The Position

Serves as Clinical Research Nurse 1 (CRN 1) for oncology clinical trials conducted in the Lombardi Clinical Trials Office of the Lombardi Comprehensive Cancer Center at Georgetown University. The role involves overall coordination of assigned clinical trials throughout their lifecycle, collaboration with investigators on participant recruitment and selection, and obtaining informed consent. The CRN 1 will coordinate or conduct study-related procedures, manage patient care across different settings, and meticulously document all study-related activities and participant data. This position also requires providing clinical and administrative nursing support, ensuring site compliance with research protocols, coordinating specimen collection, educating patients about trial participation, and conducting staff training. Additionally, the role involves updating the Clinical Trials Management System (CTMS), collaborating with data coordinators for accurate documentation and query resolution, documenting and reporting adverse events, and acting as a liaison with various internal and external stakeholders including sponsors, auditors, and hospital staff. The CRN 1 will also identify and address barriers to patient and physician participation in clinical trials and participate in meetings and committees as assigned. All duties must be performed in accordance with applicable laws, regulations, and Georgetown University Medical Center’s philosophies, policies, and SOPs, including Human Subject Protection, patient confidentiality/HIPAA, and GCP.

Requirements

Bachelor’s degree
BLS certification
RN license in the District of Columbia
Three to five (3-5) years nursing experience in a hospital, clinic, or similar health care setting
Preference for inpatient/Intensive Care Unit settings

Nice To Haves

At least one (1) year of clinical research experience preferred
At least one (1) year of oncology experience preferred
Knowledge of clinical research, research processes, and Good Clinical Practice (GCP)
Excellent verbal and written communication, organizational skills, and attention to detail
Reliable and able to prioritize competing responsibilities

Responsibilities

Responsible for overall coordination of assigned clinical trials throughout the trial lifecycle.
Collaborate with investigators by participating in recruitment and selection of study participants; document and collect data to support protocol screening, and determine compliance with eligibility requirements.
Interface with study participants and obtain and document informed consent according to protocol, institutional policies, and regulatory guidelines.
Coordinate or conduct study-related procedures and assessments while maintaining protocol integrity and patient safety and in accordance with Good Clinical Practice (GCP) guidelines.
Assist in the assessment, management, and coordination across the continuum of care (outpatient, inpatient, and home) including triage of phone calls, symptom management, and proactive patient communication.
Document all study related activity, including medical data, in the participant’s medical record and when applicable, the patient research chart, in compliance with protocol, sponsor, and departmental requirements.
Conduct follow-up with study participants in accordance with established standards and protocols.
Provide clinical and administrative nursing support to Clinical Research Coordinators and other CRN positions.
Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.
Coordinate collection of research specimens per protocol requirements with CRCs.
Provide patient education about clinical trial participation, treatment, potential side effects, and required testing.
Schedule/conduct in-service training for appropriate staff on assigned clinical trials.
Regularly update the Clinical Trials Management System (CTMS) with patient information and key dates to support responsible financial management of clinical trials with CRCs.
Collaborate with Data Coordinator(s) to assure the documentation for the clinical trial is complete and accurate; assist with query resolution in a timely manner.
Document and report serious adverse events per protocol and institutional policy.
Act as a liaison with hospital staff, physicians, IRB, review committees, clinical research finance team, and auditors.
Act as a liaison with sponsors during study start-up activities and participate in site initiation visits, monitoring visits, and audits.
Identify potential barriers to patient and physician participation in clinical trials; develop and implement methods to alleviate those barriers.
Actively participate in meetings, task forces, and committees as assigned.
Perform all duties in accordance with applicable laws and regulations. Adhere to Georgetown University Medical Center’s philosophies, policies, and SOPs. Work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP.