Clinical Research Nurse - pediatric oncology
oncology, clinical trials, data management, pediatrics
The Center for Cancer Research (CCR) is working to solve the most pressing problems in the field through basic, translational and clinical cancer research to create the cancer medicines of tomorrow and is dedicated to preparing the next generation of cancer researchers. Read more about CCR, the benefits of working at CCR and hear from our staff on their CCR experiences.
We are the NCI’s internal, federally funded cancer center where world leading physician-scientists working on the cutting edge of medicine developing clinical trials of new sometimes “first-in-human” drugs and new treatment approaches. Closely knit clinical support teams are providing excellent quality of care of our patients and carrying out our clinical protocols with professionalism and compassion at the world’s largest dedicated research hospital on the NIH campus in Bethesda, Maryland. Join our unique and rewarding clinical team.
This position description does not represent a current opening but may be used to identify candidates with skills and experience for positions within Leidos Biomedical Research that frequently become available. Candidates who express an interest may be considered for future positions at Leidos Biomedical Research.
- The Clinical Research Directorate (CRD) provides clinical research nursing support for the NCI, CCR, Pediatric Oncology Branch (POB).
- Alerts physicians of adverse events, abnormal outcomes or problematic trends, specifically in regards to protocol mandates
- Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
- Assists the Principal Investigator (PI) in data collection (including patient specimens) and data analysis; writing interim reports, annual protocol reports, and scientific publications; interpretation of research data for the protocol team; and performing site visits
- Completes flow sheets and case report forms according to the provisions of approved investigational protocols
- Coordinates Clinical Trial Agreement requirements with applicable Clinical Research Oversight Managers (e.g., safety reporting requirements) and data management if data is to be provided to third party at end of trial
- Appropriately screens and collects blood samples from patients and donors
- Assists in managing patient files, copying and organizing research data
- Collaborates with the patient’s community physician and other health care providers to further the continuity of care and protect the integrity of the clinical research trial/data
- Conducts updates for clinical staff on patient care, protocol process and progress, human subject’s protection, ICH GCPs, and quality assurance education
- Consults with other health care professionals to meet medical, psychological and/or social patient needs
- Coordinates patient schedules and provides information for a successful visit to meet the required protocol procedures, data collection time points and nursing care
- Develops patient rapport and assists in explaining the protocol and tests/procedures to the patients
- Discusses toxicities experienced and drugs/dosages received by patient while at home
- Documents patient care via established guidelines
- Maintains communication with the patient’s home physicians to ensure any ongoing home care is in accordance with the protocol guidelines
- Recognizes and supports the needs of data integrity and retrieval, and interpret needs appropriately for PIs, patients and other staff members
- Recruits and enrolls patients
- Ensures scientific quality and human subject’s protection
- Collects and interprets data as specified by the investigators in support of the clinical trial including drug administration, toxicity, laboratory parameters and response interpretation
- Coordinates and reviews daily operations and logistics
- Ensures the communication of study changes to all care givers
- Interacts with auditing and monitoring agencies to facilitate the exchange of data
- Interfaces with the Protocol Support Office
- Manages and coordinates intramural and extramural sites participating in clinical protocols for which the Principal Investigator is the coordinating center
- Manages dose modifications and/or other modifications of the treatment regimen made in response to toxicity, pharmacokinetics, and tissue studies
- Obtains informed consent
- Orders lab, x-rays and other diagnostic procedures prescribed by the protocol and/or clinically indicated
- Oversees ongoing protocol operations to ensure study compliance and troubleshoot possible protocol violations
- Participates in the management and evaluation of multiple international clinical protocols
- Provides support top the research team for research in an emerging clinical area to include clinical trial support for combination therapies and translational research
- Serves as liaison between investigators, the IRB and the study DSMB
- Works with the participating Branches within CCR to maintain protocol compliance and adherence
- Must possess a degree or diploma from a professional nursing program approved by a legally designated State accrediting agency at the time the program was completed
- Current State license as a registered nurse (RN)
- Foreign degrees must be evaluated for U.S. equivalency
- A minimum of one (1) year nursing and/or related clinical research experience
- Knowledge of clinical research data collection and clinical data report preparation
- Demonstrated experience in the coordination, implementation, and execution of clinical trials
- Ability to work in a data management setting in the capture and analysis of patient data including toxicity assessment, drug administration, laboratory results, and tumor response
- Must be able to obtain and maintain a security clearance
- Oncology experience
- Experience in a clinical trials outpatient setting and/or experience in data management and collection
- Experience in pediatric oncology, transplant and/or neuro-oncology
Please reference job id req635 for all inquiries.
Hiring for this position will be through Leidos Biomedical Research, Inc., a wholly owned subsidiary of Leidos, Inc. Leidos Biomedical is the operations and technical support contractor for the Frederick National Laboratory for Cancer Research, a federal national laboratory.
Bethesda is located adjacent to Washington, D.C. and is an urban core of Montgomery County, MD. Bethesda is one of the most affluent and highly educated communities in the United States. It is a vibrant town, and a destination for shopping, dining and artistic and cultural events.
HHS, NIH, and NCI are Equal Opportunity Employers