Home




Protocol Research Nurse Coordinator (NCI)

APPLY NOW    
Job Number:
640830
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.


JOB DESCRIPTION

The Clinical Monitoring Research Program provides Clinical Research Nursing support to the NIAID’s Division of Infectious Disease Laboratory in coordinating clinical research protocols that support basic and applied research.

 
The Protocol Nurse Coordinator:
  • Provides assistance for all aspects of the protocol lifecycle including initial IND submission, IRB submission, continuing review applications, protocols, protocol amendments, annual reports, and protocol inactivation with IRB and FDA
  • Creates and maintains an IRB database of approved amendment descriptions
  • Conducts updates for clinical staff on patient care, protocol process and progress, human subject’s protection, ICH, GCPs and quality assurance education
  • Coordinates with investigators and medical writers to ensure IRB and FDA stipulations are appropriately addressed timely
  • Alerts physicians of adverse events, abnormal outcomes or problematic trends, specifically in regard to protocol mandates
  • Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
  • Drafts source documents to be utilized in new studies
  • Assists the Principal Investigator in data collection (including patient specimens) and data analysis; the writing of interim reports, annual protocol reports, and scientific publications; the interpretation of research data for the protocol team; and with performing site visits
  • Completes flow sheets and case report forms according to the provisions of approved investigational protocols
  • Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
  • Works with the Clinical Trials Management Clinical Research Oversight Manager to ensure consistency of case report forms with the management plan and coordinates site initiations and other monitoring site visits with all necessary parties
  • Assists with protocol development and associated approvals from a variety of laboratories
  • Appropriately screens and collects blood samples from patients and donors
  • Collaborates with the patient’s community physician and other health care providers to further the continuity of care and protect the integrity of the clinical research trial/data


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) or a diploma from a professional nursing program that is an accredited state agency in the U.S.
  • Prior experience in adult/pediatric clinical trials management
  • Prior experience in data management and collection
  • Foreign degrees must be evaluated for U.S. equivalency
  • In addition to education requirements, a minimum of five (5) years progressively responsible nursing experience
  • Possession of a current professional license as a Registered Nurse (RN) from any U.S. state
  • Knowledge of clinical research data collection and clinical data report preparation
  • Demonstrated experience in the coordination, implementation and execution of clinical trials
  • Working knowledge of biological principles and scientific methods
  • Ability to develop patient rapport
  • Ability to work in a data management setting in the capture and analysis of patient data, including toxicity assessment, drug administration and laboratory results
  • Working knowledge of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines
  • Ability to troubleshoot and report unexpected problems that may arise during the conduct of these trials
  • Must be able to obtain and maintain a security 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.
Other Locations:  
APPLY NOW