Clinical Research Nurse II - NIH / NIAID

Clinical Research Nurse II - NIH / NIAID

Job ID: req4543
Employee Type: exempt full-time
Division: Clinical Research Directorate
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA

The Frederick National Laboratory is 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 to the National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR), and the Laboratory of Clinical Immunology and Microbiology (LCIM).

KEY ROLES/RESPONSIBILITIES

Provides clinical support to an assigned caseload of research protocols (including, but not limited to):

• 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

• Provides patient care to protocol patients
  • Triages patient concerns and medical conditions
  • Understands the conduct of study protocol
  • Handles research samples, collects and delivers them,
  • Coordinates and schedules patients’ study protocol visits
    • Schedules required labs, diagnostic tests, consults
    • Updates system calendars with patient schedules
    • Works with the travel team to arrange patient travel and lodging
    • Communicates the schedule to patients
    • Obtains consents for the release of medical records

• 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 with coordination, handling, and shipment of study samples
• 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
• This position is full-time and fully onsite in Bethesda, Maryland

BASIC QUALIFICATIONS

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

• Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
• Possession of a current unencumbered professional license as a Registered Nurse (RN) from any U.S. state
• Experience in managing complex study schedules
• Ability to work with sponsor provided electronic data systems and to enter required information
• 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:

• Experience in the fields of infectious disease, immunology, autoimmunity, and chronic illness disease processes
• Experience in clinical trials and/or experience in data management and collection
• Highly effective computer and communication skills
• Must be organized and detailed oriented

JOB HAZARDS

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

Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, 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.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement.

76,800.00 - 110,103.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions