Clinical Research Nurse III - GMB

Location
Bethesda, MD, USA
Posted
Oct 30, 2018
Ref
req135
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Within the Leidos Biomedical Research Inc. the Clinical Monitoring Research Program Directorate (CMRPD) 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, CMRPD'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. CMRPD'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, CMRPD 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. CMRPD'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 Directorate (CMRPD) provides comprehensive clinical and administrative support to the National Cancer Institute's, Center for Cancer Research (CCR), Genitourinary Malignancies Branch (GMB).

KEY ROLES/RESPONSIBILITIES
  • Provides assistance for all aspects of the protocol lifecycle, including initial Investigational New Drug (IND) submission; Institutional Review Board (IRB) submission; study participant recruitment and enrollment; informed consent; site visits; data collection, analysis, and interpretation; writing interim and annual reports; continuing review applications; protocol amendments; and protocol inactivation with IRB and the Food and Drug Administration (FDA)
  • Orders labs, x-rays, and other diagnostic procedures prescribed by the protocol and/or clinically indicated
  • Distributes test kits, coordinates outside specimens for testing and diagnostic purposes, and logs received samples in the appropriate database
  • Oversees ongoing protocol operations to ensure study compliance and troubleshoot possible protocol violations
  • Alerts physicians of adverse events, abnormal outcomes, and/or problematic trends
  • Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
  • Appropriately screens and collects blood samples from study participants 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
  • Conducts updates for clinical staff on patient care, protocol process and progress, human subject protection, International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), and quality assurance education
  • Develops rapport with the patients and assists in explaining the protocol and tests/procedures to the patients
  • Discusses toxicities experienced and drugs/dosages received by patient while at home
  • Manages dose modifications and/or other modifications of the treatment regimen made in response to toxicity, pharmacokinetics, and tissue studies
  • Trains and assists study staff in explaining the protocol and tests/procedures to the study participants
  • Participates in quality improvement and assurance initiatives involving database and data system development efforts, as well as training programs for research nurses
  • Coordinates with Principal Investigators (PIs) and Medical Writers to ensure IRB and FDA stipulations are appropriately addressed in a timely manner
  • Works directly with PIs and Medical Writers on the production and revision of clinical research protocols and facilitates the activities of writing and regulatory review
  • Interacts with auditing and monitoring agencies to facilitate the exchange of data, 18) interfaces with the Protocol Support Office
  • Provides support to the research team including clinical trial support for combination therapies and translational research
  • Serves as a liaison between the PIs, the IRB, and the study Data Safety Monitoring Board
  • This position is located at the NIH campus in Bethesda, Maryland

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
  • Experience with adult patient populations
  • Prior research nurse experience with clinical trials in an outpatient setting
  • Data management and collection experience
  • Experience in the coordination, implementation, and execution of clinical trials
  • Ability to capture and analyze patient data including toxicity assessment, drug administration, laboratory results and tumor response
  • Must be able to obtain and maintain a clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:
  • Knowledge of clinical data report preparation
  • Knowledge of basic behavioral science and counseling theory and principles
  • Knowledge of clinical research protocol design, development, interpretation, implementation and evaluation
  • Knowledge of the research process, including problem identification, literature review, proposing hypothesis, research data collection, statistical analysis of data and the recommendation of findings
  • Ability to apply knowledge to the clinical care of cancer patients
  • Ability to provide emotional support in helping patients cope with stress associated with cancer

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)​​