Protocol Nurse Coordinator II

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 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
• Possession of a current professional license as a Registered Nurse (RN) from any U.S. state
• A minimum of two (2) years progressively responsible nursing experience
• 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

• Masters preparation in nursing, research, or a related discipline
• Prior experience in adult/pediatric clinical trials management
• Ability to perform word processing and spreadsheet applications independently with accuracy and speed
• General knowledge of biological principles and scientific methods is preferred

JOB HARZARDS OR REQUIREMENTS

• 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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