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

Description

Protocol Nurse Coordinator II - NIH / NIAID

Job ID: req1595
Employee Type: exempt full-time
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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest.  

 Position Overview:

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 nursing support services for clinical research being conducted at the HIV/AIDS outpatient clinics within the National Institutes of Allergy and Infectious Diseases' (NIAIDs) Division of Intramural Research (DIR).

KEY ROLES/RESPONSIBILITIES

• Supports the investigation of novel approaches to the management of influenza, HIV, and other important infectious agents
• Coordinates and facilitates research studies, study participant visits, data collection and consultation with other health care professionals
• Alerts the appropriate study team member of adverse events, abnormal outcomes or problematic trends
• Enters protocol data into a database management system
• Participates in clinical trial protocol planning
• Develops procedure manuals for clinical trial protocols
• Assists with the creation and completion of case report forms and data capture methods
• Provides oversight of ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations. Interface/coordinate with the Internal Review Board to ensure proper and timely filing of SAEs, amendments, annual reports, and other regulatory documents
• Updates clinical staff on study participant-related issues, protocol process and progress, human subject's protection, ICH Good Clinical Practices, and quality assurance measures
• Provides assistance to the Principal Investigator in interpreting research data for the protocol team
• This position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

• 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 progressively responsible nursing experience
• Possession of a current professional license as a Registered Nurse (RN) from any U.S. state
• Knowledge of clinical research data collection and clinical data report preparation
• Working knowledge of ICH-GCPs
• Experience working in a data management setting to capture and analyze patient data including; toxicity assessment, drug administration and laboratory results as they relate to the diagnosis and treatment of HIV infection and AIDS
• Working knowledge of the related disciplines of epidemiology, microbiology, immunology, serology, pharmacology, clinical medicine and biostatistics
• Ability to wear Personal Protective equipment or PPE
• Must be CPR certified or certifiable
• Must be able 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 is preferred
• Prior experience in adult/pediatric clinical trials management is preferred
• Ability to perform word processing and spreadsheet applications independently with accuracy and speed
• General knowledge of biological principles and scientific methods is preferred
• Five (5) years progressively responsible nursing experience

JOB HARZARDS 

• 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)

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