Leidos Protocol Nurse Coordinator II (NCI) in BETHESDA, Maryland

Description:

PROGRAM DESCRIPTION

Within 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.

The CMRP provides study coordination services for the NIAID, DCR, ICMOB, Laboratory of Immunoregulation (LIR)

JOB DESCRIPTION/BASIC FUNCTION

The Protocol Nurse Coordinator II will:

  • Support the investigation of novel approaches to the management of influenza, HIV, and other important infectious agents

  • Coordinate and execute research studies, patient schedules, data collection and nursing care and consultation with other health care professionals

  • Orders protocol-mandated tests, labs and procedures

  • Alert physicians of adverse events, abnormal outcomes or problematic trends

  • Enter protocol data into a database management system

  • Participate in clinical trials protocol planning

  • Develop procedure manuals for clinical trials protocols

  • Assist with the creation of case report forms and data capture methods

  • Provide 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

  • Update clinical staff on patient care, protocol process and progress, human subject’s protection, ICH Good Clinical Practices, and quality assurance education

  • Provide assistance to the Principal Investigator in interpreting research data for the protocol team

Qualifications:

BASIC 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) in a related field or four (4) years in lieu of degree

  • Foreign degrees must be evaluated for U.S. equivalency

  • Must be able to obtain and maintain a Public Trust Clearance

  • Possession of a current professional license as a Registered Nurse (RN) from any U.S. state

  • A minimum of five (5) 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

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Prior experience in adult/pediatric clinical trials management

  • General knowledge of biological principles and scientific methods

Leidos Overview:

Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos is an Equal Opportunity Employer.