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Protocol Nurse Coordinator II job in Bethesda at Frederick National Laboratory for Cancer Research

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Protocol Nurse Coordinator II at Frederick National Laboratory for Cancer Research

Protocol Nurse Coordinator II

Frederick National Laboratory for Cancer Research Bethesda, MD Full-Time
Protocol Nurse Coordinator II

Job ID: req2941
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.


WithinLeidos Biomedical Research Inc., the Clinical Research Directorate (CRD),various clinical support teams provide high-quality comprehensive and strategicoperational support to the high-profile domestic and international clinicalresearch initiatives of the National Cancer Institute (NCI), National Instituteof Allergy and Infectious Diseases (NIAID), Clinical Center (CC), NationalHeart, Lung and Blood Institute (NHLBI), National Institute of Arthritis andMusculoskeletal and Skin Diseases (NIAMS), National Center for AdvancingTranslational Sciences (NCATS), National Institute of Neurological Disordersand Stroke (NINDS), the National Institute of Mental Health (NIMH) and theNational Institute of Environmental Health Sciences (NIEHS). CRD's supportservices are strategically aligned with the program's mission to providecomprehensive, dedicated support to assist National Institutes of Health (NIH)researchers in providing the highest quality of clinical research in compliancewith applicable regulations and guidelines, maintaining data integrity, andprotecting human subjects. For the scientific advancement of clinical research,CRD services include comprehensive clinical trials monitoring, regulatory,pharmacovigilance, protocol navigation and development, and programmatic andproject management support for facilitating the conduct of 400+ Phase I, II,and III domestic and international trials on a yearly basis. These trialsinvestigate 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 andconditions; parasitic infections; rheumatic and inflammatory diseases; and rareand neglected diseases. CRD's collaborative approach to clinical research andthe expertise and dedication of staff to the continuation and success of theprogram's mission has contributed to improving the overall standards of publichealth on a global scale.

The Clinical Research Directorate(CRD) provides clinical research nursing coordination and support to theNational Institute of Allergy and Infectious Diseases (NIAID), Division of ClinicalResearch (DCR), Intramural Clinical Management and Operations Branch (ICMOB).

  • Provides protocol management to an assigned caseload of researchprotocols (including, but not limited to):
  • Assists with clinicalprotocol development
  • Ensures compliance withregulatory requirements
  • Develops protocolprocedure manuals
  • Manages clinical protocols
  • Obtains consent forclinical trial enrollment
  • Confirms eligibility ofvolunteers for participation in clinical trials
  • Communicates with patientsand referring providers about the protocol and enrollment process
  • Coordinates the newpatient referral process
  • Oversees protocoloperations to ensure study compliance
  • Monitors data trends andalerts study team
  • Problem-solves protocolviolations
  • Visits study sitelocations (intramural and extramural) PRN
  • Coordinates researchspecimen procurement and processing
  • Ensures regulatorycompliance
  • Completes and submitsrequired regulatory documents in a timely manner
  • Interfaces with NIH IRB toensure timely filing of required reports
  • Assists clinical staffwith clinical implementation of the protocol
  • Work collaboratively in amulti-disciplinary environment
  • Appropriately delegateclinical and research tasks
  • This position is not credentialed for patient care
  • Trains staff (intramuraland extramural)
  • Creates and providesprotocol initiation and update trainings
  • This position is not credentialed for patient care
  • This position is located in Bethesda, MD



To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
  • Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirement, a minimum of two (2) years of progressively responsible relevant experience
  • Possession of a current unencumbered professionallicense as a Registered Nurse (RN) from any U.S. state
  • Ability to wear personal protective equipment
  • Must be CPR certified or certifiable
  • Highly effective organizational and planning, problem-solving, andinterpersonal skills
  • Highly effective computer skills
  • Working knowledge of biological principles and scientific methods
  • Working knowledge of International Conference onHarmonization/Good Clinical Practices (ICH/GCP) guidelines, clinical researchconcepts, ethics, processes, and clinical protocol implementation
  • Workingknowledge of HIV/AIDS and viral infections pathophysiology, disease trajectory,and clinical management principles
  • Ability to obtain and maintain a security clearance


Candidates with these desired skills will be given preferential consideration:
  • Masters preparation in nursing,research, or a related discipline
  • Prior experience in adult clinicaltrials coordination and/or project management

  • This position is subject to working with or have potential for exposure to infectious
    material, requiring medical clearance and immunizations
  • This position is subject to atmospheric conditions that would require the usage of a
    respirator, requiring a medical clearance

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


Recommended Skills

  • Biology
  • Cpr
  • Certified Nurse Practitioner
  • Clinic Management Systems
  • Clinical Research
  • Clinical Trials
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