732-661-0400

Clinical Research Nurse

  • Location: Bethesda, MD
  • Type: Direct Hire
  • Job #33158

National Institutes of Health (NIH) 

The incumbent will provide support to one of more of the Institute’s Branches/Sections/Laboratories as designated by the Office of Research Nursing.  This is a clinical research position, with primary responsibilities of protocol implementation which includes research, patient education, quality assurance and implementation of nursing practices and consultation. The incumbent functions within a team of clinical providers and clinical support staff  (Staff Clinicians, Nurse Practitioners, Data Managers, Protocol Navigators, Protocol and Patient Care Coordinators as well as other NIH Clinical Center staff) to ensure the coordination, implementation and execution of the Institute’s clinical trials.

 

Position Duties include:

  • 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 CC 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 of a study-specific database
  • Manages study-specific electronic database
  • Coordinates research participant study visits
  • Facilitates scheduling and coordination of study procedures
  • Provides direct nursing care to research participants (Example: interact with research participants to provide nursing care, administration of research interventions, specimen collection, follow-up calls, etc.)
  • Provides education to research participant and family research study participation, participant’s current clinical condition, and/or disease process
  • Monitors research participant and report potential adverse events to a member of the research team
  • Records research data (Example: document vital signs, administration of a research compound, participant responses, etc.) in approved source document (example: the 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 accurate and complete IRB submissions
  • Participates in quality assurance initiatives (respond to queries, assist with attribution of adverse events, attend weekly meeting with data management staff, and respond to monitoring and auditing reports
  • Participates in study initiation, monitoring and close out visits
  • Assists in providing resolution to participant inquiries and concerns

 

REQURIED BACKGROUND

  • Bachelor’s degree in Nursing with current state nursing licensure
  • Professional knowledge of the principles, theories, techniques, and practices of nursing with immunologic illnesses
  • Experience in a clinical research environment
  • Knowledge of clinical research data collection and clinical data report preparation
  • Knowledge of ICH­ GCPs
  • Prior experience in a clinical trials management required
  • Must be CPR certified or certifiable
  • Knowledge of Microsoft Office Suite (MS Word, Excel, Outlook) and spreadsheet applications
  • Strong communications skills, both oral and written
  • Excellent analytical, organizational and time management skills
  • Ability to participate in efforts to ensure scientific quality and human subjects’ protection
  • Ability to oversee ongoing protocol operations to ensure study compliance; troubleshoot possible protocol violations

 

LOCATION

The world famous Building 10 on NIH’s main campus in Bethesda Maryland

 

IND123
 

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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