Clinical Research Nurse 1

Clinical Research Nurse 1 (CRN 1) 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. Additional duties include, but are not limited to: 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. Other duties 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.Work Interactions Clinical Operations Team Manager Disease Group members: Principal Investigators, Physicians, Clinicians Lombardi Clinical Trials Office team members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory and Tissue Technicians, Investigator Initiated Trials Office staff, and Clinical Research Support staff External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff Clinical trial sponsors, auditors, and study monitors

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 and AAP positions can be found on the Department of Human Resources website.

If you are a qualified individual with a disability and need a reasonable accommodations for any part of the application and hiring process, please visit the Office for Equal Opportunity Compliance website for general information about requesting accommodations, as well as information about requesting accommodations specifically for applicants. You also can also contact the Office for Equal Opportunity Compliance at (202) 687-4798 or oeoc@georgetown.edu.Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.