Clinical Research Nurse III - NCI Pediatric Oncology Branch (POB)
Company: Frederick National Laboratory
Location: Bethesda
Posted on: May 25, 2023
Job Description:
Clinical Research Nurse III - NCI Pediatric Oncology Branch
(POB)
Job ID: req3501
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892
USA
The Frederick National Laboratory is a Federally Funded Research
and Development Center (FFRDC) sponsored by the National Cancer
Institute (NCI) and operated by Leidos Biomedical Research, Inc.
The lab addresses some of the most urgent and intractable problems
in the biomedical sciences in cancer and AIDS, drug development and
first-in-human clinical trials, applications of nanotechnology in
medicine, and rapid response to emerging threats of infectious
diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity
and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., the Clinical Research
Directorate (CRD), various clinical support teams provide
high-quality comprehensive and strategic operational support to the
high-profile domestic and international clinical research
initiatives of the National Cancer Institute (NCI), National
Institute of Allergy and Infectious Diseases (NIAID), Clinical
Center (CC), National Heart, Lung and Blood Institute (NHLBI),
National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), National Center for Advancing Translational
Sciences (NCATS), National Institute of Neurological Disorders and
Stroke (NINDS), the National Institute of Mental Health (NIMH) and
the National Institute of Environmental Health Sciences (NIEHS).
CRD's support services are strategically aligned with the program's
mission to provide comprehensive, dedicated support to assist
National Institutes of Health (NIH) researchers in providing the
highest quality of clinical research in compliance with applicable
regulations and guidelines, maintaining data integrity, and
protecting human subjects. For the scientific advancement of
clinical research, CRD services include comprehensive clinical
trials monitoring, regulatory, pharmacovigilance, protocol
navigation and development, and programmatic and project management
support for facilitating the conduct of 400+ Phase I, II, and III
domestic and international trials on a yearly basis. These trials
investigate the prevention, diagnosis, treatment of, and therapies
for cancer, influenza, HIV, and other infectious diseases and
viruses such as hepatitis C, tuberculosis, malaria, and Ebola
virus; heart, lung, and blood diseases and conditions; parasitic
infections; rheumatic and inflammatory diseases; and rare and
neglected diseases. CRD's collaborative approach to clinical
research and the expertise and dedication of staff to the
continuation and success of the program's mission has contributed
to improving the overall standards of public health on a global
scale.
The Clinical Research Directorate (CRD) provides clinical research
nursing support for the National Cancer Institute (NCI), Center for
Cancer Research (CCR), Pediatric Oncology Branch (POB).
KEY ROLES/RESPONSIBILITIES
- Alerts physicians of adverse events, abnormal outcomes, or
problematic trends, adhering to protocol mandates and ensures
proper and timely filing of these occurrences
- Creates and maintains IRB database of approved amendment
descriptions
- 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
- Works with the Clinical Trials Management Research Oversight
Manager to ensure consistency of case report forms with the
management plan and coordinate site initiation and other monitoring
site visits with all necessary parties
- Appropriately screens and collects blood samples from patients
and donors per protocol schema
- 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
- Coordinates patient schedules and provides information for a
successful visit to meet the required protocol procedures, data
collection time points and nursing care
- Defines, establishes, and manages inclusion criteria such as
patient population, diagnostic criteria, and patient
condition
- 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
- Maintains communication with the patient's home physicians to
ensure any ongoing home care is in accordance with the protocol
guidelines
- Recruits and enrolls patients
- Assists in the identification of the responsible party for data
input into ClinicalTrials.gov at study conclusion, as
applicable
- Participates in quality improvement and quality assurance
initiatives involving database and data system development efforts
as well as training programs for research nurses
- Collects and interprets data as specified by the investigators
in support of the clinical trial including drug administration,
toxicity, laboratory parameters and response
interpretation
- Collects and maintains current regulatory documentation from
numerous ongoing clinical trials
- Interacts with auditing and monitoring agencies to facilitate
the exchange of data
- Interfaces with the Protocol Support Office
- Manages dose modifications and/or other modifications of the
treatment regimen made in response to toxicity, pharmacokinetics,
and tissue studies
- Manages implementation, tracking, data abstraction, collection,
data reporting and coordination of a variety of Phase III clinical
trials
- Obtains informed consent
- Serves as liaison between investigators, the IRB, and the study
DSMB
- Works with site staff to put systems in place to ensure timely
resolution of queries
- Works with the participating Branches within CCR to maintain
protocol compliance and adherence
- This position is location at the National Institutes of Health
(NIH) in Bethesda, Maryland
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the
knowledge, skills, and abilities listed below:
- Possession of a Bachelor's degree in a related field from an
accredited college or university according to the Council for
Higher Education Accreditation (CHEA). Additional qualifying
experience may be substituted for the required education
- 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
- In addition to the educational requirements, a minimum of five
(5) years 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
- Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential
consideration:
- Ability to apply knowledge to the clinical care of cancer
patients
- Ability to provide emotional support in helping patients cope
with stress associated with cancer
- Experience in a clinical trials outpatient setting and/or
experience in data management and collection
JOB HAZARDS
- This position is subject to atmospheric conditions that would
require the usage of a respirator, requiring a medical
clearance
Commitment to Diversity
All qualified applicants will receive consideration for employment
without regard to sex, race, ethnicity, age, national origin,
citizenship, religion, physical or mental disability, medical
condition, genetic information, pregnancy, family structure,
marital status, ancestry, domestic partner status, sexual
orientation, gender identity or expression, veteran or military
status, or any other basis prohibited by law. Leidos will also
consider for employment qualified applicants with criminal
histories consistent with relevant laws.
#readytowork
Keywords: Frederick National Laboratory, Bethesda , Clinical Research Nurse III - NCI Pediatric Oncology Branch (POB), Healthcare , Bethesda, Maryland
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