Clinical Research Nurse II

Clinical Research Nurse 2

Serves as Clinical Research Nurse 2 for the Cellular Therapy Program oncology clinical trials conducted in the Lombardi Clinical Trials Office of the Lombardi Comprehensive Cancer Center at Georgetown University. Incumbent duties include, but are not limited to:

• Responsible for overall coordination of assigned clinical trials throughout the trial lifecycle.
• Collaborate with investigators and more senior study team members 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 and sponsor requirements.
• Conduct follow-up with study participants in accordance with established standards and protocols.
• Provide clinical and administrative nursing support to CRC and 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 Clinical Research Coordinators.
• 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 Clinical Research Coordinators.
• 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 and Work Mode Designation

• 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
• External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff
• Clinical trial sponsors, auditors, and study monitors

Requirements and Qualifications

• Bachelor's degree, BLS certification, and RN license in the District of Columbia required
• Three to five (3-5) years nursing experience in a hospital, clinic, or similar health care setting required
• At least two (1) year of clinical research experience required.
• At least one (1) year of oncology and/or Cellular Medicine experience preferred
• Experience working inpatient/Intensive Care Unit settings
• Knowledge of clinical research, research processes, and Good Clinical Practice (GCP)
• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Reliable and able to prioritize competing responsibilities

Work Mode Designation

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. 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.

Pay Range:

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:

$54,616.00 - $100,493.33

Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.

EEO Statement:

GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.

Benefits:

Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.