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Accrual Site Coordinator (NCI)

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Job Number:
646917
Job Category:
Healthcare / Life Sciences / Medical
Location:
BETHESDA, MD US
Schedule:
Full-time
Travel:
None
Shift:
Day Job
Potential for Teleworking:
No
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
Public Trust
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 Clinical Monitoring Research Program provides project operations and subcontract management support for the National Cancer Institute’s (NCI’s) Center for Cancer Research Neuro-Oncology Branch.  This position provides support to the Brain Tumor Trials Collaborative (BTTC). The BTTC is a network of clinical sites with the expertise to participate in state of the art clinical trials investigating new treatments for malignant brain tumors (https://ccr.cancer.gov/neuro-oncology-branch/bttc). 

KEY ROLES/RESPONSIBILITIES

The Clinical Research Nurse III/Accrual Site Coordinator:

  • Monitors and oversees activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials
  • Assists 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
  • Participates in clinical trial protocol development
  • 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
  • Interacts with auditing and monitoring agencies to facilitate the exchange of data
  • Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
  • Ensures quality and human subjects protection
  • Assists the Principal Investigator in interpreting research data for dissemination to the protocol team
  • May conduct updates for clinical staff on patient care, protocol process and progress, human subjects protection, International Conference on Harmonization/Good Clinical Practices, and quality assurance education
  • May visit off-site collaborative centers
  • Will primarily provide high level administrative and coordination support to the BTTC with very limited interaction with study participants

This position is located 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
  • Current State license as a registered nurse (RN)
  • Foreign degrees must be evaluated for U.S. equivalency
  • A minimum of one (1) year nursing and/or related clinical research experience
  • Knowledge of clinical research data collection and clinical data report preparation
  • Experience in the coordination, implementation, and execution of clinical trials
  • Oncology experience
  • 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
  • Ability to communicate effectively
  • Must be able to obtain and maintain a clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Experience in a clinical trials outpatient 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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