Job 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), 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 CRD provides clinical research nursing support for the NCI's Center for Cancer Research (CCR), Women’s Malignancy Branch.
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 coordinates 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.
Qualifications and Job Details
Required and Preferred Skills
- 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
- Must be able to obtain and maintain a security clearance
- 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
About the NCI Center for Cancer Research
The Center for Cancer Research (CCR) is home to nearly 250 basic and clinical research groups located on two campuses just outside of Washington, D.C. CCR is part of the National Cancer Institute (NCI) and makes up the largest component of the research effort at the National Institutes of Health (NIH). Centrally supported by long-term funding and a culture of complete intellectual freedom, CCR scientists are able to pursue the most important and challenging problems in cancer research. We collaborate with academic and commercial partners and advocacy groups across the world in efforts to prevent, diagnose and treat cancer and HIV/AIDS. The CCR research portfolio covers the full spectrum of biological and biomedical research. Our work ranges from basic to translational and clinical, and our clinical trials are conducted in the NIH Clinical Center, the world’s largest hospital dedicated to clinical research that offers a robust infrastructure to support CCR’s patients on an estimated 250 open studies. The success of CCR is grounded in an exceptionally strong discovery research program that provides the foundation for the seamless translation of insights from bench to bedside. Read more about CCR, the benefits of working at CCR and hear from our staff on their CCR experiences.
Bethesda
Bethesda is one of the most highly educated communities in the United States and has a nationally renowned school system. The city is a thriving suburban center close to Washington, D.C., and home to many restaurants, retailers and a flourishing arts and entertainment district.
Apply at: https://leidosbiomed.csod.com/ats/careersite/search.aspx?site=4&c=leidosbiomed
“Please reference job id REQ3410 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.
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)