Clinical Research Nurse III-Cancer Moonshot (NCI) Job in Maryland (MD), Research and Development - cGMP Career, Full Time Jobs in Leidos Biomedical Research, Inc.
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Clinical Research Nurse III-Cancer Moonshot (NCI) job in BETHESDA

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Leidos Biomedical Research, Inc. jobs
Maryland (MD), BETHESDA
Job Code:  660963
Employer:  Leidos Biomedical Research, Inc.
Category:  Research and Development - cGMP
Job Type:  Full Time

Location
Country:  United States
State:  Maryland (MD)
City:  BETHESDA
Map: 
09/10/2018

Description
Description:

PROGRAM DESCRIPTION

Within the Leidos Biomedical Research Inc.'s Clinical Research Directorate, 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 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). CRD'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, CRD 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. 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 Program Directorate (CRD) provides clinical research nursing support to the NCI's Center for Cancer Research (CCR), Neuro-Oncology Branch (NOB).

This is a fantastic and exciting opportunity for a high-level research nurse to join our multidisciplinary NCI-CONNECT team to advance the understanding of rare adult brain and spine cancers and improve approaches to care and treatment. NCI-CONNECT is a program within the Rare Tumor Patient Engagement Network (RTPEN), an initiative supported by the Cancer Moonshot initiative. RTPEN aims to advance research and discover new treatments for rare tumors through a collaborative network of national and international institutions that will provide expertise, personalized health care and education to patients with rare tumors.

KEY ROLES/RESPONSIBILITIES

The Clinical Research Nurse III (CRN III):


- Coordinates community-based, national and international multi-institutional studies sponsored by the Cancer Moonshot initiative and the Brain Tumor Trials Collaborative (BTTC)
- Participates in patient recruitment and retention activities
- Registers patients on protocol with the NCI and pharmaceutical company if applicable
- Develops and utilizes protocol specific resources, such as patient education tools
- Coordinates and assures completion of protocol required patient evaluations
- Coordinates scheduling, acquisition, and disposition of protocol required biologic specimens
- Monitors and oversees activities pertaining to clinical protocols such as patient accrual, trial progress, and the need for extension or renewal of ongoing trials
- Participates in clinical trial protocol development, assisting with writing protocols and protocol amendments to ensure regulatory requirements
- Oversees ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations
- Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
- Interfaces with the Protocol Support Office
- Collaborates with other NIH departments/outside facilities to maintain protocol integrity and support ongoing patients participating in protocols
- Develops procedure manuals for clinical trial protocols
- Assists in the creation of case report forms
- Trains staff
- Advises on and participates in the management and evaluation of multiple clinical protocols
- Coordinates and participates in site monitoring visits and audits
- Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
- Assures quality of data and human subjects protection
- Assists the Principal Investigator in interpreting research data for dissemination to the protocol team
- Has an opportunity to prepare and/or present data for publication/presentation and to participate in writing/editing manuscripts
- This position is location at the National Institutes of Health (NIH) in Bethesda, Maryland

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
- Foreign degrees must be evaluated for U.S. equivalency
- Current State license as a registered nurse (RN)
- A minimum of one (1) year nursing and/or related clinical research experience
- Knowledge of clinical research data collection and clinical data report preparation
- Demonstrated experience in the coordination, implementation, and execution of clinical trials
- Ability to work in a data management setting in the capture and analysis of patient data including toxicity assessment, drug administration, laboratory results, and tumor response
- Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:


- Oncology experience
- Experience in a clinical trials outpatient setting and/or experience in data management and collection
- Prior clinical research coordinator experience

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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.

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