Protocol Nurse Coordinator II - NIH/ NIAID in Bethesda, MD

Description

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), Laboratory of Parasitic Diseases (LPD).

KEY ROLES/RESPONSIBILITIES

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

• Assists with clinical protocol development
  • Ensures compliance with regulatory requirements
  • Develops protocol procedure manuals
• Manages clinical protocols
  • Obtains consent for clinical trial enrollment
    • Confirms eligibility of volunteers for participation in clinical trials
    • Communicates with patients and referring providers about the protocol and enrollment process
    • Coordinates the new patient referral process
  • Oversees protocol operations to ensure study compliance
    • Monitors data trends and alerts study team
    • Problem-solves protocol violations
    • Visits study site locations (intramural and extramural) PRN
    • Coordinates research specimen procurement and processing
  • Ensures regulatory compliance
    • Completes and submits required regulatory documents in a timely manner
    • Interfaces with NIH IRB to ensure timely filing of required reports
  • Assists clinical staff with clinical implementation of the protocol
    • Work collaboratively in a multi-disciplinary environment
    • Appropriately delegate clinical and research tasks
• Manages caseload of assigned patients
  • Ensures visits are scheduled within protocol timelines
  • Enters orders as agent for provider using defined protocol order sets
    • Modifies protocol order sets as needed to maintain accuracy
  • Coordinates procurement and shipment of patient samples from outside providers
  • Arranges interpreter services for participants who are not fluent in English or have other impairments to reading or understanding English (i.e., deaf; legally blind)
    • Ensures appropriate consent procedures are followed
• Trains staff (intramural and extramural)
  • Creates and provides protocol initiation and update trainings
• This position is not credentialed for patient care
• This position is located in Bethesda, MD
• This position is primarily onsite with the possibility of occasional telework

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). 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 the education requirement, 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
• Highly effective computer 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
• Working knowledge of infectious pathophysiology, disease trajectory, and clinical management principles
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Masters preparation in nursing, research, or a related discipline
• Prior experience in clinical trials coordination and/or project
• Bilingual, English-Spanish a plus
• Comfortable caring for pediatric and adult participants

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 have potential for exposure to infectious material, requiring medical clearance and immunizations