Clinical Research Nurse 1 - Lombardi Comprehensive Cancer Center - Georgetown University Medical Center
Georgetown University
- USA
- Permanent
- Full-time
- Administer 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 Clinical Research Coordinator and Clinical Research Nurse 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; and 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; and 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 SOP
- Work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP
- Clinical Operations Team Manager
- Disease Group members: Principal Investigators, Physicians, Clinicians
- Lombardi Clinical Trials Office (CTO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians
- External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff
- Clinical trial sponsors, auditors, and study monitors
- Bachelor’s degree, BLS certification, and RN license in the District of Columbia required.
- 3 to 5 years nursing experience in a hospital, clinic, or similar health care setting – preference for up to 2 years of clinical research experience
- Strong candidates exhibit: ♦ 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