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Job Details

Clinical Research Nurse NCI

Company name
Leidos

Location
Bethesda, MD

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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 Clinical Research Nurse III provides direct support to clinical trials management and provides regulatory support to Phase I/II clinical trials being conducted by the National Institute of Health's National Heart, Lung, and Blood Institute (NHLBI).

KEY ROLES/RESPONSIBILITIES

Participates in research participant recruitment

Participates in screening potential research participants for eligibility

Obtains all appropriate outside records to support prior history, treatments, and eligibility and sends to NIH Clinical Center Medical Records Department

Facilitates the initial and ongoing informed consent or assent process

Collaborates with the interdisciplinary team to create and communicate a plan of care that allows for safe and effective collection of clinical research data

Contributes to the development of case report forms

Develops study-specific materials for research participant education

Participates in the setup and management of study-specific databases

Coordinates research participant study visits

Facilitates scheduling and coordination of study procedures

Educates the research participant and family on participant’s current clinical condition and/or disease process

Monitors research participant and reports potential adverse events to a member of the research team

Records research data (vital signs, administration of a research compound, participant responses, etc.) in approved source document (medical record, case report forms, etc.)

Participates in the identification and reporting of research trends

Collaborates with Protocol Navigator to maintain accurate and complete regulatory binder

Participates in Institutional Review Board (IRB) submissions

Participates in quality assurance initiatives (responds to queries, assists with attribution of adverse events, attends weekly meeting with data management staff, and responds to monitoring and auditing reports)

Participates in study initiation, monitoring and close out visits

Assists in providing resolution to participant inquiries and concerns

Qualifications:

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

Must possess a degree or diploma from a professional nursing program approved by a legally designated State accrediting agency at the time the program was completed

Possession of a current professional license as a registered nurse (RN) from any U.S. state

Foreign degrees must be evaluated for U.S. equivalency

In addition to the RN requirements, a minimum of one (1) year progressively responsible nursing/clinical experience

Ability to function independently and/or collaboratively within a team setting

Highly effective problem-solving, planning and organizational skills

Experience effectively managing complex research programs in a large institutional setting

Working knowledge of clinical research concepts, ethics, processes and protocol implementation and management

Background knowledge in clinical trials or pharmaceutical projects

Must be Basic Life Support (BLS) certified

Must be able to obtain and maintain a security clearance

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

Case management experience in a pharmaceutical, biotechnology and/or clinical environment and/or Certified Case Manager (CCM) credential

Experience in a hematology or oncology setting

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 will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.

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Company info

Leidos
Website : http://www.leidos.com

Company Profile
We bring a mix of innovative technology and sector expertise to customers in national security, health, and infrastructure. We look for solutions that not only transform businesses, but change the world.

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