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Protocol Nurse Coordinator II - Infectious Disease (NIH)

Job ID: req1166
Employee Type: exempt full-time
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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

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 nursing care support services for the clinical research being conducted at the National Institute of Allergy and Infectious Diseases' (NIAIDs) Division of Intramural Research (DIR), Medical Virology Section of the Laboratory of Infectious Diseases (LID) located at the National Institutes of Health (NIH) in Bethesda, Maryland. 

KEY ROLES/RESPONSIBILITIES

This position is located in Bethesda, Maryland and supports the investigation of novel approaches to the management of infectious diseases by providing: 

Clinical Research Protocol Support

  • Participates in clinical trial protocol development, including the development of procedure manuals and case report forms
  • Participates in the recruitment and enrollment of eligible research participants
  • Monitors research participant recruitment/retention and trial progress
  • Monitors for and troubleshoots abnormal outcomes, adverse events, problematic trends and/or protocol violations
  • Coordinates and facilitated data collection/entry, completion and filing of case report forms
  • Assists in the interpretation of research data for the protocol team
  • Liaisons with Internal Review Boards to ensure proper and timely filing of serious adverse events, amendments, continuing reviews/study extensions, annual reports, and other regulatory documents
  • Provides protocol education and updates for clinical staff on study participant-related issues, protocol process and progress, human subject’s protection, ICH Good Clinical Practices, and quality assurance measures 

Clinical Care Support

  • Coordinates and facilitates study participant visits in consultation with other health care professionals
  • Coordinates and facilitates the collection of study participant research samples
  • Assists in the planning and assessment of protocol supported/required interventions 

BASIC QUALIFICATIONS

  • Possession of a Bachelor’s degree from an accredited college/university in a related field or four (4) years related experience in lieu of degree
  • Foreign degrees must be evaluated for U.S. equivalency
  • A minimum of two (2) years progressively responsible nursing and/or clinical trials management experience
  • Current State license as a registered nurse (RN)
  • Demonstrated experience with clinical research data collection methods and report preparation related to the capture and analysis of clinical patient data
  • Working knowledge of nursing practices associated with infectious diseases and ICH/GCP
  • Ability to function independently and/or collaboratively within a team setting. Demonstrated highly effective problem-solving, planning and organizational skills
  • Ability to effectively manage complex research programs in a large institutional setting
  • Strong working knowledge of clinical research concepts, ethics, processes and protocol implementation and management
  • Must be CPR certified or able to obtain/maintain certification
  • General knowledge of related disciplines, such as epidemiology, microbiology, immunology, serology, pharmacology, clinical medicine and biostatistics
  • Must be able to obtain and maintain security clearance 

PREFERRED QUALIFICATIONS

  • Experience in adult/pediatric clinical trials management
  • Knowledge of biological principles and scientific methods 

JOB HARZARDS OR REQUIREMENTS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
  • This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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