Job ID: req4092
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., 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 comprehensive, dedicated clinical research, nursing, and physician support for the National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR), Laboratory of Clinical Immunology and Microbiology (LCIM), Neuroimmunological Diseases Section (NDS).
Key Roles/Responsibilities
Provides clinical care and clinical research support to an assigned caseload of research protocols (including, but not limited to):
- Ensuring compliance with applicable licensure/certification requirements, healthcare standards, governmental laws and regulations, policies, procedures maintaining clinical competence in an area of specialty practice
- Works collaboratively in a multi-disciplinary environment to provide comprehensive clinical research care to patients and clinical research volunteers
- Performs clinical assessment of patients and 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
- Performs protocol-driven and clinically indicated procedures including skin biopsies and lumbar puncture. Prior experience with procedures not required; training will be provided.
- Facilitates continuity of care across healthcare settings by communicating with outside providers
- Documents patient care and research activities in the appropriate charting systems in a timely manner
- Provides counseling, education and instruction to patients and their families regarding their diagnosis and treatment plans
- Provides medical coverage to patients at NIH Clinical Center MRI research facility. Cannot have contraindications to being close to strong magnetic fields.
- Serves as an Associate investigator and shares regulatory duties with team members
- Assists with protocol development and lifecycle
- Coordinates with referring providers to facilitate the screening and enrollment process
- Obtains consent for clinical trial enrollment
- Assists with data collection and management
- Assists in preparing and filing regulatory documents related to clinical protocols
- Assists with sample procurement and processing Disseminating research outcomes through
- Participates in clinical rounds and protocol meetings
- Provides staff trainings and mentorship
- Writes manuscripts for publication
- Present at conferences
- Ability to assume administrative responsibilities as needed and assigned
- Ability to work on-site during regular clinic hours, excluding Federal holidays. Ad hoc telework available on non-clinic days
- This position is located, in Bethesda, Maryland
Basic Qualifications
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: - A 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 have successfully completed the National Commission on Certification of Physician Assistants (NCCPA) examination.
- Must be Maryland State Board eligible
- A Nurse Practitioner applicant must possess an MSN or DNP or certificate from an accredited nurse practitioner program, approved by the legally designated State accrediting agency at the time the program was completed by the applicant.
- Must have active, current registration as professional nurse in a state, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. Must have appropriate certification issued by the American Academy of Nurse Practitioners (AANP), or the American Nurse Credentialing Center (ANCC) as a Nurse Practitioner.
- Must be Maryland State Board eligible. Certification as Family or Adult NP
- All applicants: Eligibility includes documentation of an active or pending Maryland license
- In addition to education requirements:
- Nurse Practitioner I/Physician Assistant I - No work experience required
- Nurse Practitioner II/Physician Assistant II - A minimum of two (2) years relevant clinical clinical experience
- Knowledge of relationships between diseases, health assessment, counseling, diagnostic testing procedures, broad base clinical areas such as pathophysiology, psychosocial theory, pharmacology, and primary medical management practices
- Ability to conduct studies according to established Good Clinical Practice (GCP) as defined by the Food and Drug Administration (FDA) within the Standard Operating Procedures (SOPs) and the Clinical Center’s Administrative Policies of the operational clinic
- Ability to obtain and maintain a security clearance
Preferred Qualifications
Candidates with these desired skills will be given preferential consideration:
- Nurse Practitioner I/Physician Assistant I - a minimum of two (2) years relevant clinical experience
- Nurse Practitioner II/Physician Assistant II - a minimum of five (5) years relevant clinical experience
- Prior experience with clinical trials
- Experience in a clinical research setting
- Interest in neurology
JOB HAZARDS
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, 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.
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