Nurse Case Mgr II 608030 (NCI) Job

Bethesda, Montgomery, Maryland
Sep 03, 2014
Dec 03, 2014
Full Time

Location: Bethesda, MD, US

Nurse Case Mgr II 608030 (NCI) (Job Number:608030)

The Clinical Monitoring Research Program (CMRP) provides support to clinical research being conducted by the Division of Intramural Research (DIR) National Institute of Allergy and Infectious Diseases' (NIAID) Laboratory of Infectious Diseases (LID) located at the National Institutes of Health (NIH) campus in Bethesda, Maryland. The Division of Intramural Research (DIR) conducts basic and clinical research in a wide range of disciplines related to immunology, allergy, and infectious diseases. Purpose is to make scientific discoveries that promote the development of new vaccines, therapeutics, and diagnostics to improve human health.

The Nurse Case Manager (NCM) II will be responsible to support basic and applied research for an ongoing Phase 1 herpes vaccine trial within the NIAID DIR’s Laboratory of Infectious Diseases (LID). The NCM will be responsible for all aspects of the protocol lifecycle for healthy subject volunteers and coordinating the trial by executing various aspects such as screening, enrolling, conducting vaccine visits and follow-up visits, database entry for case report forms, measuring quality assurance for Data Safety Monitoring Board (DSMB) reviews and IRB and FDA meetings/submissions. The NCM coordinates patient schedules to meet required protocol procedures, data collection time points and nursing care. Inputs and/or directs the input of patient travel and remuneration. Assists physicians in protocol required procedures to include phlebotomy and intravenous catheter placement, pharmacokinetics and intradermal antigen skin testing. Orders labs, x-rays and other diagnostic procedures prescribed by the protocol and/or clinically indicated in a computerized patient management system. The NCM II serves as the main communication liaison between the caseload of patients and other LID health care team members. Interprets trial data, drug administration, toxicity, laboratory parameters and responses. The NCM alerts physicians/team members to abnormal outcomes or problematic trends and collaborates on protocol and practice-required interventions to assure appropriate intervention is instituted for any research or health related serious adverse events (SAEs). Manages quality assurance and improvement activities and ensures proper and timely filing of SAEs, amendments, annual reports, and/or other regulatory documents. Completes flow sheets and case report forms per provisions of approved investigational protocols; recognizes data integrity. Follows up on monitoring reports ensuring adequate resolution to identified problems are addressed. The NCM will also provide direct nursing care to patients utilizing the nursing process to assess, plan, intervene and follow-up disease-related features as outlined in the clinical trial protocol. This position is located on the main campus of the National Institutes of Health (NIH) in Bethesda, Maryland.



- Possession of a current professional license as a registered nurse (RN) in the state designated by the Program requirements.

- Foreign degrees must be evaluated for U.S. equivalency.
- In addition to education requirements, a minimum of two (2) years nursing/clinical experience.

- Ability to function independently and/or collaboratively within a team setting.

- Demonstrates highly effective problem-solving, planning and organizational skills.

- Effectively manages complex research programs in a large institutional setting.

- Possesses a strong working knowledge of clinical research concepts, ethics, processes and protocol implementation and management.

- Possesses background knowledge in clinical trials or pharmaceutical projects.
- This position is subject to obtaining a Public Trust Clearance.


- Prior experience in adult/pediatric clinical trials management is preferred.
- General knowledge of biological principles and scientific methods.

- Experience with international clinical trials is a plus.

- Case management in a pharmaceutical, biotechnology and/or clinical environment and/or Certified Case Manager (CCM) credential is preferred.

For more information about the Clinical Monitoring Research Program please visit

Leidos Biomedical Research, Inc., a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute. Our focus is on basic and applied science in cancer and AIDS. We maintain an integrated suite of advanced technologies backed by scientific expertise in areas such as genetics, genomics, protein science, proteomics, bioinformatics, high-performance biomedical computing, and nanotechnology. We develop new technologies to support cutting-edge science, and we develop and manufacture clinical-grade pharmaceuticals for first-in-human trials.

Leidos Overview:Leidos is an applied solutions company focused on markets that are seeing converging business and technological trends, and address basic, enduring human needs: defense and national security, health and life sciences, and energy, engineering and infrastructure. The Company's approximately 20,000 employees serve customers in the U.S. Department of Defense, the intelligence community, the U.S. Department of Homeland Security, other U.S. Government civil agencies and commercial health and engineering markets.

Leidos is an Equal Opportunity Employer M/F/D/V.

Job Posting: Aug 12, 2014, 11:59:39 AM
Primary Location: United States-MD-BETHESDA

Clearance Level Must Currently Possess: None

Clearance Level Must Be Able to Obtain: Public Trust

Potential for Teleworking: No

Travel: None

Shift: Day Job

Schedule: Full-time

Nearest Major Market: Washington DC 
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