Clinical Research Nurse, US Military Malaria Vaccine Program

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Updated: June 10, 2017
Job ID: 212691
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

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HJF is seeking a Clinical Research Nurse to support the US Military Malaria Vaccine Program. The US Military Malaria Vaccine Program is an international leader in malaria research and serves as a premier center for malaria vaccine development. The Navy component of the program, Naval Medical Research Center, is seeking a Clinical Research Nurse to support the Clinical Trials Center (CTC) located at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. HJF provides scientific, technical and programmatic support services to WRNMMC.

Operating under minimal supervision of clinical investigators, the Clinical Research Nurse will manage and oversee the specified clinical research protocol(s) from study inception to termination. The successful candidate must possess a clear understanding of the nursing and clinical research processes and excellent organizational skills. Additionally, the successful candidate must be able to collaborate with multiple inter-disciplinary medical and research teams, exhibit excellent oral and written communication, and display a strong commitment to excellence in nursing practice, teamwork, human subjects safety, and research integrity.

Responsibilities:

  1. Educate and communicate with current and prospective human subjects regarding the research protocol(s).
  2. Arrange appointments and/or procedures for prospective human subjects; administer informed consent related to human subject screening.
  3. Administer appropriate drugs and/or vaccines to enrolled subjects as necessary.
  4. Perform basic clinical and laboratory procedures during subject clinic visits such as obtaining medical history, taking vital signs, drawing blood and obtaining other clinical, research, and immunological specimens as required.
  5. Responsible for handling and processing of clinical, research, and immunological specimens as necessary.
  6. Review study subjects' records and screen subjects for participation eligibility in research protocol(s).
  7. In collaboration with clinical investigators, determine eligibility of human subjects for clinical trials.
  8. Review protocols to ensure compliance with laboratory and clinical procedures.
  9. Provide guidance and assistance to clinical investigators in the preparation and submission of protocol(s) to the Institutional Review Board (IRB), including protocol development, initial IRB submission, IRB continuing reviews, amendments, audits and other administrative requirements.
  10. In collaboration with clinical investigators, identify problems and limitation in the research design or analysis methodology of designated protocols.
  11. Collect, organize, catalog, disseminate, and maintain appropriate files of human subject and protocol data.
  12. In collaboration with clinical investigators, prepare any adverse event and serious adverse event files and reports; ensure timely and accurate evaluation and reporting of adverse events and serious adverse events in accordance with the IRB and Food and Drug Administration (FDA) policies.
  13. Evaluate and maintain compliance with applicable internal and external regulations and guidance, to include FDA, Department of Defense, Department of the Navy, International Conference on Harmonisation (ICH), institutional review boards (IRBs), and Good Clinical Practices (GCP).
  14. Adhere to legal, professional, and ethical codes with respect to confidentiality and privacy.
  15. Performs other duties as necessary.

Required Knowledge, Skills, and Abilities: nursing experience, clinical trial experience preferred.

Minimum Education/Training Requirements:  Bachelor's degree in nursing

Minimum Experience:  2 to 4 years nursing experience; 5 years clinical trial experience preferred

Work Environment:  Office and clinical patient care area; possible evening and/or weekend hours.

Physical Capabilities: Long periods of sitting, standing, escorting patients, carrying light items (up to 10 lbs); may encounter patients who are confused, agitated, or abusive

Required Licenses, Certification or Registration: Licensed as a Registered Nurse (RN), certified in basic cardiac life support ; certification in advanced cardiac life support preferred

Other Requirements: US Citizenship required. Secret Clearance or an Interim Secret Clearance is a requirement to work at WRNMMC.

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.

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