Protocol Nurse Coordinator II/III - NIH/ NIAID

Job ID: req3267
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.

PROGRAM DESCRIPTION

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 ClinicalResearch Directorate (CRD) provides nursing support services for clinicalresearch being conducted at the HIV/AIDS outpatient clinics within the NationalInstitutes of Allergy and Infectious Diseases’ (NIAIDs) Division of IntramuralResearch's (DIR), Laboratory of Immunoregulation (LIR).

KEY ROLES/RESPONSIBILITIES

• Assists with clinical protocol development
• Ensures compliance with regulatory requirements
• Develops protocol procedure manuals
• Manages clinical protocols
• Obtains consent for clinical trial enrollment
• Confirms eligibility of volunteers for participation in clinical trials
• Communicates with patients and referring providers about the protocol and enrollment process 
• Coordinates the new patient referral process
• Oversees protocol operations to ensure study compliance 
• Monitors data trends and alerts study team
• Problem-solves protocol violations
• Visits study site locations (intramural and extramural) PRN
• Coordinates research specimen procurement and processing
• Ensures regulatory compliance
• Completes and submits required regulatory documents in a timely manner
• Interfaces with NIH IRB to ensure timely filing of required reports
• Assists clinical staff with clinical implementation of the protocol
• Work collaboratively in a multi-disciplinary environment
• Appropriately delegate clinical and research tasks
• This position is not credentialed for patient care
• Trains staff (intramural and extramural)
• Creates and provides protocol initiation and update trainings
• This position is not credentialed for patient care
• This position is located in Bethesda, MD and can accommodate up to 2 days/week of remote work

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field
• Foreign degrees must be evaluated for U.S. equivalency
• Possession of a current unencumbered professional license as a Registered Nurse (RN) from any U.S. state
  • Nurse Coord II, Protocol - In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
  • Nurse Coord III, Protocol- In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
• Ability to wear personal protective equipment
• Must be CPR certified or certifiable
• Highly effective organizational and planning, problem-solving, and interpersonal skills
• Highly effective computer skills
• Working knowledge of biological principles and scientific methods
• Working knowledge of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, clinical research concepts, ethics, processes, and clinical protocol implementation
• Ability to perform word processing and spreadsheet applications independently with accuracy and speed
• General knowledge of biological principles and scientific methods
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Masters preparation in nursing, research, or a related discipline
• Prior experience in adult clinical trials management
• Working knowledge of HIV/AIDS and viral infections pathophysiology, disease trajectory, and clinical management principles

JOB HARZARDS

• 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)
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