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Clinical Research Coordinator - NIH - LAD

Company: Regional Recreation Corporation of Wood Buffalo
Location: Bethesda
Posted on: April 8, 2021

Job Description:

Clinical Research Coordinator - NIH - LAD in Bethesda, Maryland - Careers at CAMRIS Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Returning Candidate? Log back in! Clinical Research Coordinator - NIH - LAD Job Locations US-MD-Bethesda # of Openings 1 Category NIAID Type Regular Full-Time Overview CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today's most effective, evidence-based best practices to improve the lives of people around the world.--Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, bio-defense, and clinical research. CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today! We are seeking a Clinical Research Coordinator to support the overall functions of the Laboratory of Allergic Diseases (LAD), Allergy Research Unit (FARU) at the National Institutes of Health (NIH). Responsibilities

  • Provide advanced expertise in clinical trial coordination and implementation, data and protocol
    management. Oversee the implementation, tracking, data abstraction and collection, data
    reporting, and coordination of a variety of clinical trials in affiliation with the NIAID/DIR
    program.
  • Interview, screen and recruit patients for entry onto protocols.
  • Ensure that families of participants are properly consented and understand implications of genetic
    research. Screen patients, obtain medical history, and acquire outside medical records and
    pathology specimens, while addressing complex ethical and legal implications.
  • Perform, and/or coordinate the collection, processing and handling of laboratory samples
    including appropriate storage and shipping.
  • Coordinate the procurement of samples from referring physicians worldwide to further the
    laboratory's research.
  • Monitor response to therapy and adjusts plan of care per protocol specifications, standards of
    practice, and other guidelines.
  • Use sound judgment and clinical expertise to adjust patients' plans of care in the absence of
    established guidelines.
  • Document informed consents in CRIS and CRIMSON patient medical information systems.
  • Manage protocols relating to human subjects research and the collection and processing of
    human samples procured under the auspices of NIH IRB-approved clinical research protocols.
  • Work to maintain NIH IRB protocol and office files, databases, and records. Provide
    administrative and technical guidance to investigators and institute staff on NIH IRB functions.
  • Maintain strict compliance with IRB, NIH and Federal Regulations governing human subjects
    research.
  • Stay current with NIH IRB requirements. Prepare reports and respond to outside inquiries and
    audits from IRB oversight and regulatory offices including, but not limited to, the NIH
    Intramural Research Program's Human Research Protections Program, the NIH Office of Human
    Subjects Research Protections, and the HHS Office of Human Research Protections.
  • Educate investigators and staff and assures that all NIH IRB policies and procedures are
    disseminated to supervisors and other appropriate program staff via written and electronic
    communication.
  • Provide training to clinic staff with regard to Investigator Brochure information, protocol
    implementation, general and specific data collection and research practices.
  • Direct health care members in the execution of trials and resolution of logistical constraints and
    assures all aspects of Good Clinical Practice (GCP) and federal regulatory requirements are met
    or exceeded.
  • Educate families on basic concepts of the human immune system and hereditary disease as it
    relates to their illness.
  • Establish rapport and works with families under stress, provide emotional support and refers to
    appropriate resources.
  • Process and guide research protocols through the review cycle of submission, initial review,
    continuing review, amendments, and reporting. Obtain translations of protocol consents into
    various languages and updates translated consents as needed. Arrange for translators in advance
    of protocol visits.
  • Assist in preparing and analyzing clinical data for publication in biomedical journals.
  • Serve as a primary contact point for the Laboratory for protocol procedures and regulations.
  • Provide administrative and technical guidance for new investigators.
  • Conductseducational presentations to nursing units, clinics and other departments collaborating
    on NIAID clinical trials.
  • Ensure compliance with training for protection of human subjects, conflict of interest guidelines,
    and patient confidentiality. Ensure accurate and timely entry of data to bio-specimen databases.
  • Maintain integrity of databases by conducting periodic audits and reports to Laboratory chief.
  • Provide advice and expertise to technicians on maintaining Clinical Laboratory Improvement
    Amendment (CLIA) certification for the Laboratory where appropriate and participates in CLIA
    inspections.
  • Serve as a primary contact point for the Laboratory in regard to protocol procedures, regulations
    and requirements. Serves as the liaison between various individuals and offices involved in the
    oversight of human subjects research at the NIH including, but not limited to, the NIH IRB, the
    NIAID Clinical Director, the Office of Human Subjects Research, the NIH Office of Clinical
    Research, NIH Clinical Center Office of Protocol Services, Deputy Ethics Coordinators,
    NIAID's Technology Transfer and Intellectual Property Office (TTIPO), and investigators.
  • Serve as the liaison between Laboratory and other teams in NIAID, clinical nursing staff, NIH
    Clinical Center Staff, other institutes and centers of the NIH, extramural collaborators, referring
    physicians, patients and their families.
  • Participate in the development and maintenance of hard copy and electronic systems to prepare,
    monitor and track protocols and submissions. Participate in the development and maintenance of
    systems used to manage databases and to monitor compliance with applicable regulations.
    Maintain files and records on all protocols for the required periods of time.
  • Creatively solve problems related to obtaining viable patient samples from international locations
    and from patients with limited resources.
  • Collaborate with many of the following professionals and/or organizations: pharmacy,
    laboratories, pharmaceutical agencies/sponsors and monitors, Contract Research Organizations,
    the Food and Drug Administration, and the Institutional Review boards and IND holders.
  • Direct and perform quality assurance and quality control activities as they relate to protocol
    adherence, protocol monitoring, data collection, data abstraction, and data analysis and assures
    standard operating procedures reflect the highest standards of data integrity and patient safety.
  • Report data to appropriate regulatory and monitoring agencies. Anticipates and creates
    database/case reports to meet protocol needs. Translate data collection needs into clinic wide
    standards and tools, collaborating with resources beyond the intramural setting to maintain data
    collection tools.
  • Pursue activities to facilitate the ease of reporting, avoidance of repetition of data entry
    procedures, and generation of reports appropriate to various agencies.
  • Design and maintain a selection of material appropriate to send to health care referral sources
    seeking eligibility information or for other appropriate objectives.
  • Analyze data, note trends and implications of same, publishes and presents finding locally,
    nationally and internationally representing NIAID and DIR.
  • Serve in formal or informal leadership positions and is recognized as an expert in a clinical or
    research specialty area. Serves as a consultant and role model for professional practice,
    collaboration and communication.
  • Use advanced communication skills to problem solve complex or unpredictable situations and to
    improve processes and services to patients and colleagues.
  • Write expert documents relevant to research, clinical care and related subjects including
    published works and executive reports.
  • Act as a mentor to students and nurse specialists/practitioners new to the NIAID/ NIH Clinical
    Center environment. Provide formal education to others in the field of expertise including
    lecturing at colleges and continuing education programs.
  • Participate in clinical practice and research support peer review and develops multidisciplinary
    performance improvement programs and projects. Maintain an overview of the clinical program
    in order to collaborate and contributes to planning and resource allocation.
  • Collaborate with peers and other multidisciplinary team members to analyze and evaluate current
    systems of health care delivery and to identify and implement new practice patterns as
    appropriate. Participate in outside activities that enhance personal and professional growth and
    development. Qualifications
    • All support positions required a minimum of a BS degree; some require a MS, MD, or Ph.D.
    • The education, skills and relevant years of experience required for each support position
      are consistent with those identified as the minimum requirements for the labor categories
      specified in the contract.
    • Thorough and comprehensive knowledge of the purpose and function of IRBs and regulations
      governing IRBs, including 45 CFR part 46 and 21 CFR part 56. Thorough knowledge of NIH
      OHSR IRB standard operating procedures, and other policies regarding IRB review and human
      subject research safety.
    • Clinical Research Coordinator:
      • Must have BSN or MSN degree, and a valid Nursing license. Options Apply for this job online Apply Share Refer this job to a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading... Need help finding the right job? We can recommend jobs specifically for you!Click here to get started. Application FAQs Software Powered by iCIMS
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Keywords: Regional Recreation Corporation of Wood Buffalo, Bethesda , Clinical Research Coordinator - NIH - LAD, Healthcare , Bethesda, Maryland

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