Advanced Practice Provider - NP or PA II/III - NIAID / NIH in Bethesda, MD
Within 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 quality Nurse Practitioner clinical research services in support of the overall functions of the Laboratory of Clinical Immunology and Microbiology (LCIM), Division of Intramural Research (DIR), National Institute of Allergy & Infectious Diseases (NIAID).
***This position can be hired as a Nurse Practitioner or Physician Assistant II or III.
- Provides expert clinical care and clinical research support to an assigned caseload of research protocols (including, but not limited to):
- Ensures compliance with applicable licensure/certification requirements, healthcare standards, governmental laws and regulations, policies, procedures
- Maintains clinical competence in an area of specialty practice
- Works collaboratively in a multi-disciplinary environment to provide comprehensive clinical research care to clinical research volunteers
- Performs clinical assessment of clinical research volunteers as dictated by the protocol and/or the volunteer's clinical condition
- Monitors results, recognizes abnormal outcomes/problematic trends, and communicates findings to the principal investigator and study team members as appropriate
- Provides protocol-driven and clinically indicated medical interventions
- Facilitates the care continuity across healthcare settings (NIH Clinical Center and outside hospitals/providers)
- Accurately and timely documents patient care and research activities in the appropriate charting systems
- Serves as an Associate Investigator
- Assists with protocol development and lifecycle
- Coordinates with outside referring providers to facilitate the screening and enrollment process
- Obtains consent for clinical trial enrollment
- Assists with data collection and management
- Assists with sample procurement and processing
- Disseminates research outcomes
- Participates in clinical rounds and protocol meetings
- Provides staff trainings
- Writes manuscripts for publication
- Presents at conferences
- 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. Foreign degrees must be evaluated for U.S. equivalency
- Nurse Practitioner: Possession of a current unencumbered professional license as a Registered Nurse (RN) from any U.S. state. Applicant must be a graduate from a nurse practitioner educational program, accredited by the Accreditation Commission for Education in Nursing (ACEN) or Commission for Collegiate Nursing Education (CCNE), at a college, university, or educational institution that is accredited by an accrediting body or organization recognized by the Secretary, U.S. Department of Education. Must have appropriate certification issued by the appropriate certifying body such as the American Academy of Nurse Practitioners (AANP) or the American Nurse Credentialing Center (ANCC)Must have appropriate certification issued by the appropriate certifying body such as the American Academy of Nurse Practitioners (AANP) or the American Nurse Credentialing Center (ANCC).
- Physician Assistant: Applicant must be a graduate from a physician assistant educational program, accredited by the Accreditation Review Committee on Education for the Physician Assistant (ARC-PA) or its predecessors, at a college, university, or educational institution that is accredited by an accrediting body or organization recognized by the Secretary, U.S. Department of Education
- Must be Maryland State Board eligible. Eligibility includes documentation of a pending Maryland license
- Level II: In addition to educational requirements, a minimum of two (2) years of progressively responsible Nurse Practitioner or Physician Assistant experience
- Level III: In addition to educational requirements, a minimum of five (5) years of progressively responsible Nurse Practitioner or Physician Assistant experience
- Ability to wear personal protective equipment
- Must be CPR certified or certifiable
- Must be able to obtain and maintain a security clearance
- Strong working knowledge of biological principles and scientific methods
- Proficiency in the understanding and application of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines and clinical research concepts, ethics, and processes to effectively implement clinical protocols
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.
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