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Protocol Nurse Coordinator II (COVID-19)

Job ID: req1717
Employee Type: exempt full-time
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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides 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), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD’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, CMRPD 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. CMRPD’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 Monitoring Research Program Directorate (CMRPD) provides specialized support for initiatives and special projects sponsored by the National Institute of Allergy and Infectious Diseases Division of Clinical Research (DCR). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and other emerging and re-emerging infectious diseases. 

KEY ROLES/RESPONSIBILITIES

Regulatory Responsibilities:

  • Provides assistance with all aspects of the protocol lifecycle including initial IND submission, IRB submission, continuing review applications, protocols, protocol amendments, annual reports, and protocol inactivation with IRB and FDA
  • Creates and maintains an IRB database of approved amendment descriptions
  • Conducts updates for protocol process and progress, human subject’s protection, ICH, GCPs and quality assurance education
  • Coordinates with investigators and medical writers to ensure IRB and FDA stipulations are appropriately addressed timely
  • Alerts physicians of adverse events, abnormal outcomes, or problematic trends, specifically in regard to protocol mandates
  • Coordinates various activities to ensure proper and timely filing of Serious Adverse Events, amendments, annual reports, and other regulatory documents
  • Drafts source documents to be utilized in new studies
  • Assists the Principal Investigator in data collection (including patient specimens) and data analysis; the writing of interim reports, annual protocol reports, and scientific publications; the interpretation of research data for the protocol team; and with performing site visits
  • Completes flow sheets and case report forms according to the provisions of approved investigational protocols
  • Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
  • Works with the Clinical Trials Management Clinical Research Oversight Manager to ensure consistency of case report forms with the management plan and coordinates site initiations and other monitoring site visits with all necessary parties
  • Assists with protocol development and associated approvals from a variety of laboratories

Clinical Responsibilities:

  • Assists with recruitment, informed consent and assess process and documentation and scheduling of new patients to NIH protocol visits
  • Appropriately screens and ensures appropriate blood sample collection from patients and donors
  • Collaborates with the patient’s community physician and other health care providers to further the continuity of care and protect the integrity of the clinical research trial/data
  • This position is located at the NIH campus in Bethesda, Maryland

BASIC QUALIFICATIONS

  • Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) or a diploma from a professional nursing program that is an accredited state agency in the U.S..  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
  • In addition to the education requirement, a minimum of two (2) years progressively responsible protocol coordinator experience
  • Prior experience in adult/pediatric clinical trials management
  • Prior experience in data management and collection
  • Knowledge of clinical research data collection and clinical data report preparation
  • Demonstrated experience in the coordination, implementation and execution of clinical trials
  • Working knowledge of biological principles and scientific methods
  • Ability to develop patient rapport
  • Ability to work in a data management setting in the capture and analysis of patient data, including toxicity assessment, drug administration and laboratory results
  • Working knowledge of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines
  • Ability to troubleshoot and report unexpected problems that may arise during the conduct of these trials
  • 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/pediatric clinical trials management
  • Ability to perform word processing and spreadsheet applications independently with accuracy and speed
  • General knowledge of biological principles and scientific methods 

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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