Protocol Nurse Coordinator II/III

Protocol Nurse Coordinator II/III

Job ID: req4058
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

Within Leidos Biomedical Research Inc., the Clinical Research Directorate (CRD), various clinical support teams provide high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CRD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate 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 and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CRD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Research Directorate (CRD) provides nursing support services for clinical research being conducted within the National Institutes of Allergy and Infectious Diseases’ (NIAIDs) Division of Intramural Research's (DIR), Laboratory of Immunology and Microbiology (LCIM).

KEY ROLES/RESPONSIBILITIES

Provides protocol management to an assigned caseload of research protocols (including, but not limited to):

• 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
    • Facilitates the procurement of outside medical records and materials
    • Organizes, files, and reviews outside medical records
  • Oversees protocol operations to ensure study compliance
    • Monitors data trends and alerts study team
    • Problem-solves protocol violations
    • Present at the study site
    • Communicates with the CROs supported by the study sponsor
    • Responsible for entering study data to the CROs database
  • Ensures regulatory compliance
    • Completes and submits required regulatory documents in a timely manner
    • Interfaces with NIH IRB to ensure timely filing of required reports
    • Works with study monitors, prepares for and participates in medical monitor reviews
    • Assists clinical staff with clinical implementation of the protocol
    • Work collaboratively in a multi-disciplinary environment
    • Appropriately delegate clinical and research tasks
  • Coordinates research specimen procurement and processing
    • Obtains consent for send in samples
    • Assists with specimen procurement procedures
    • Assists with coordination, handling, and shipment of study samples
    • Logs received samples in appropriate databases.
    • Processes outside material through the appropriate NIH departments
  • Manages and analyzes protocol data
    • Organizes study files
    • Maintains databases
  • Assists with the monitoring of and compliance with regulatory requirements
  • Assists with the creation and preparation of protocol training materials
  • Works collaboratively in a multidisciplinary environment to assist clinical staff with clinical implementation of the protocol
• 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 onsite in Bethesda, MD with the possibility of occasional telework

**THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL**

BASIC QUALIFICATIONS

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  
• 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 experience including managing clinical research protocols or directly related work
  • Nurse Coord III, Protocol - In addition to the education requirement, a minimum of five (5) years of experience including managing clinical research protocols or directly related work
• 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
• 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 clinical trials study coordination, especially investigational new drug studies
• Knowledge and experience with clinical care or research trials in patient populations with immune deficiencies, cancer susceptibility or infectious diseases
• Comfortable working with pediatric and adult participants

JOB HAZARDS

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

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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