Protocol Nurse Coordinator III (NCI)

Leidos Biomedical Research, Inc.
Bethesda, MD
Jun 19, 2017
Jun 21, 2017
Full Time
PROGRAM DESCRIPTIONWithin the Leidos Biomedical Research Inc.'s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides 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 Institute of 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), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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. CMRP'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.JOB DESCRIPTION/BASIC FUNCTIONThe Clinical Monitoring Research Program (CMRP) is responsible for providing clinical care support for the National Institute of Allergy and Infectious Diseases' (NIAIDs) Division of Clinical Research (DCR), Intramural Clinical Management and Operations Branch (ICMOB). The Protocol Nurse Coordinator III will: Provide direct nursing support to outpatient clinical programs within the Laboratory of Immunoregulation (LIR) within the HIV and emerging infectious diseases outpatient clinic. Coordinates all aspects of protocol development, implementation, and maintenance Advise on and participates in the management and evaluation of multiple clinical infectious diseases protocols with particular emphasis on HIV, hepatitis, and emerging infectious diseases, as well as influenza studies Be responsible for recruiting, consenting, and screening potential subjects for research participation. Instrumental in study start-up; initiates the loading of data specifics into the research database; develops documentation guidelines and flow sheets for clinical trials protocols; trains research staff, and works closely with laboratory staff to ensure the accurate collection of research specimens Oversee activities pertaining to clinical protocols such as: monitoring patient recruitment and retention; trial progress; and the need for extension or renewal of ongoing trials Alert physician of adverse events, abnormal outcomes or problematic trends. Troubleshoots unexpected problems that may arise during the conduct of clinical trials Assist the scientific investigators in the writing of protocols and protocol amendments to ensure that all appropriate regulatory elements are included Work closely with Principal Investigators (PI) to submit regulatory documents to the appropriate agencies, including the IRB, FDA, and Sponsor Oversee ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations Interface with the NIAID IRB to ensure proper and timely filing of SAEs, amendments, annual reports, and other regulatory documents Closely monitors the documentation and data regarding adverse events according to protocol. Identifies deficiencies in documentation and communicates corrective measures to parties involved Work closely with other NIAID research staff to ensure the accurate and timely completion of case report forms and other data and clinical documentation needs necessary to clinical research studies. Interfaces with monitoring organizations and is the point of contact for monitoring issues Communicate with monitoring agencies to facilitate the exchange of data and safety Facilitate the exchange of data with auditing agencies and safety boards Be responsible for ensuring that identified problems are adequately addressed and resolved. Conducts updates for clinical staff on patient care, protocol process and progress, human subject protection, ICH good Clinical Practices, and quality assurance education Be responsible for staff supervision, interviews potential candidates, and writes and conducts performance reviews according to policy Be responsible for writing and contributing to periodic contract status and annual reports. Serves as liaison between program staff and customer clientBASIC QUALIFICATIONS:To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for US equivalency Possesses a minimum of eight (8) years of progressively responsible nursing experience, including supervisory experience Possession of a current professional license as a Registered Nurse (RN) from any US state Must be CPR certified or certifiable Knowledge of clinical research data collection and clinical data report preparation Working knowledge of ICH/GCPs Experience working in a data management setting in the capture and analysis of patient data, including toxicity assessment, drug administration and laboratory results as they relate to the diagnosis and treatment of HIV infection and AIDS Professional knowledge of the principles, theories, techniques and practices of nursing with immunologic illnesses, such as HIV and AIDS Working knowledge of the related disciplines of epidemiology, microbiology, immunology, serology, pharmacology, clinical medicine and biostatistics Ability to work independently and to troubleshoot unexpected problems that may arise during the conduct of clinical trials Previous experience with hiring and evaluating staff Must be able to obtain and maintain a security clearancePREFERRED:Candidates with these desired skills will be given preferential consideration: Masters preparation in nursing, research, or a related discipline Prior experience in adult clinical trials management is preferred Ability to operate word processing and spreadsheet applications independently with accuracy and speed General knowledge of biological principles and scientific methods

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