Clinical Research Nurse II - NIH / NIAID

Clinical Research Nurse II - NIH / NIAID

Job ID: req3203
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. (operator of the Frederick National Laboratory for Cancer Research), the Clinical Research Directorate (CRD) provides clinical supervision of programs at the clinical end of the research spectrum. The quality assurance programs provide the required autonomy and transparency of Good Manufacturing Practice quality assurance operations. CRD also provides operational support for clinical research and supports clinical trials management, regulation, pharmacovigilance, and protocol development/protocol navigations. These support services include dedicated clinical research professionals who provide patient care to clinical trial participants at the National Institutes of Health (NIH) Clinical Center, and other research services that support the domestic and international clinical research initiatives of the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and several other institutes within NIH. CRD’s support services are strategically aligned with its mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, protecting human subjects, and helping to advance scientific clinical research. CRD facilitates the conduct of NIH-sponsored clinical trials that investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, parasitic infections, heart, lung and blood disorders, and rare and neglected diseases. CRD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CRD’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 coordination and support of the overall functions of the Lyme Disease Studies Unit of the Laboratory of Clinical Immunology and Microbiology (LCIM), Division of Intramural Research (DIR), National Institute of Allergy & Infectious Diseases (NIAID).

KEY ROLES/RESPONSIBILITIES

• Recruits patients for clinical protocols
  
• Screens referrals
  
• Communicates with patients and referring providers about the protocol and enrollment process 
  
• Documents screening activities in appropriate databases
  
• Assists in determining eligibility of volunteers for participation in clinical trials
  
• Obtains informed consent
  
• Facilitates the procurement of outside medical records and materials
  
• Organizes, files, and reviews outside medical records
  
• Coordinates research specimen procurement and processing
  
• Obtains consent for send in samples
  
• Assists with specimen procurement procedures
  
• Logs received samples in appropriate databases
  
• Processes outside material through the appropriate NIH departments
  
• Assists in the coordination and implementation of clinical trials
  
• Manages and analyzes protocol data
  
• Organizes study files
  
• Maintains databases
  
• Assists with the monitoring of and compliance with regulatory requirements
  
• Assists with the creation and preparation of protocol training materials
  
• Works collaboratively in a multidisciplinary environment to assist clinical staff with clinical implementation of the protocol
  
• The position is not credentialed for patient care
  
• Ability to work on-site during regular clinic hours Monday - Friday, excluding Federal holidays. Ad hoc telework available as determined by clinical and protocol needs
  

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 from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field. Additional qualifying experience may be substituted for the required education
• Foreign degrees must be evaluated for U.S. equivalency
• Possession of a current unencumbered professional license as a Registered Nurse (RN) from any U.S. state
  
• In addition to educational requirements, a minimum of two (2) years of recent nursing/clinical experience
  
• Ability to wear personal protective equipment
  
• Must be CPR certified or certifiable
  
• Highly effective organizational and planning, problem-solving, and interpersonal skills
  
• Working knowledge of biological principles and scientific methods
  
• Working knowledge of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, clinical research concepts, ethics, processes, and clinical protocol implementation
  
• Ability to obtain and maintain a security clearance
  

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Prior experience in tickborne diseases desirable along experience in  clinical trials and/or experience in data management and collection
  
• Highly effective organizational, computer, and communication skills
  

JOB HAZARDS 

• 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)

#readytowork