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Clinical Research Nurse (NCI)

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Job Number:
645961
Job Category:
Information Technology - Databases
Location:
BETHESDA, MD US
Schedule:
Full-time
Travel:
None
Shift:
Day Job
Potential for Teleworking:
No
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
Public Trust
Description:

PROGRAM DESCRIPTION

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides 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 Institute of 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), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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.  CMRP’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 Monitoring Research Program (CMRP) provides clinical research nursing support to the NCI’s Center for Cancer Research (CCR), Office of Research Nursing (ORN).

KEY ROLES/RESPONSIBILITIES

The Clinical Research Nurse III (CRN III) will:

  • Alert physicians of adverse events, abnormal outcomes or problematic trends, specifically in regards to protocol mandates
  • Coordinate various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
  • Assist 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
  • Complete flow sheets and case report forms according to the provisions of approved investigational protocols
  • Coordinate 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 screen and collect blood samples from patients and donors
  • Assist in managing patient files, copying and organizing research data
  • Collaborate 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
  • Conduct updates for clinical staff on patient care, protocol process and progress, human subject’s protection, ICH GCPs, and quality assurance education
  • Consult with other health care professionals to meet medical, psychological and/or social patient needs
  • Coordinate patient schedules and provide information for a successful visit to meet the required protocol procedures, data collection time points and nursing care
  • Develop patient rapport and assist in explaining the protocol and tests/procedures to the patients
  • Discuss toxicities experienced and drugs/dosages received by patient while at home
  • Document patient care via established guidelines
  • Maintain communication with the patient’s home physicians to ensure any ongoing home care is in accordance with the protocol guidelines
  • Recognize and support the needs of data integrity and retrieval, and interpret needs appropriately for PIs, patients and other staff members
  • Recruit and enroll patients
  • Ensure scientific quality and human subject’s protection
  • Collect and interpret data as specified by the investigators in support of the clinical trial including drug administration, toxicity, laboratory parameters and response interpretation
  • Coordinate and review daily operations and logistics
  • Ensure the communication of study changes to all care givers
  • Interact with auditing and monitoring agencies to facilitate the exchange of data
  • Interface with the Protocol Support Office
  • Manage and coordinate intramural and extramural sites participating in clinical protocols for which the Principal Investigator is the coordinating center
  • Manage dose modifications and/or other modifications of the treatment regimen made in response to toxicity, pharmacokinetics, and tissue studies
  • Obtain informed consent
  • Order labs, x-rays and other diagnostic procedures prescribed by the protocol and/or clinically indicated
  • Oversee ongoing protocol operations to ensure study compliance and troubleshoot possible protocol violations
  • Work 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:

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • 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)
  • 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

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Oncology experience
  • Experience in a clinical trials outpatient setting and/or experience in data management and collection


Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.
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