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Senior Research Regulatory Coordinator - Research Translational

Company: Nationwide Children's Hospital
Location: Columbus
Posted on: September 24, 2022

Job Description:

Research Regulatory Coord Senior - Research TranslationalThe Senior Research Regulatory Coordinator plays an integral role in the regulatory/compliance process of all clinical research conducted in the NCH/RI system. This process includes human subjects research project submissions to the Institutional Review Board (IRB), submission of Investigational New Drug Applications (IND?s) to the U.S. Food and Drug Administration (FDA), overseeing the preparation & submission of regulatory/compliance documents to study sponsors and assistance with quality improvement initiatives. The position requires a working knowledge of federal regulations including FDA, National Institute of Health (NIH), Department Health and Human Services (DHHS); International Conference on Harmonization Good Clinical Practices (ICH GCP), study protocols and IRB policy, as well as an understanding of the day to day clinical research process.The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Childrens Hospital, Where Passion Meets Purpose.Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission. Were 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world well never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.Ask anyone with a Nationwide Childrens badge what they do for a living. Theyll tell you its More Than a Job. Its a calling. Its a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.Nationwide Childrens Hospital. A Place to Be Proud.PRINCIPAL DUTIES AND RESPONSIBILITIES

  • Reviews study protocols in order to write consent/assent documents and develop the initial IRB submission; submits protocol amendments; responds to contingencies and obtains final approval of documents from sponsor and IRB, on behalf of principal investigator.
  • Serves as liaison between study sponsors and the research team (IRB, research staff and Principal Investigator) regarding regulatory matters in the IRB submission and approval process.
  • Responsible for the preparation, submission and maintenance of documents and processes related to investigator-initiated drug/device projects.
  • Serves as liaison with federal agencies as needed.
  • Oversees the creation and maintenance of regulatory documents and the study administrative binder required for the clinical research project.
  • Maintains current knowledge of federal research regulations by reviewing current publications and attending conferences.
  • Advises management of regulation changes and projected impact within Clinical Research Services and the institution.
  • Primary resource to provide guidance to investigators and research staff on federal regulations, good clinical practices and IRB policies and systems.
  • Identifies protocol content which may conflict with federal and/or local requirements or practice.
  • Assists with quality improvement audits, including the administrative binder, subject research records, case report forms and other study documents.
  • Responsible for data required for CCTS annual report and other metrics as required.KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:Education:
    • Bachelor's degree or equivalent experience in medical/science field.
    • CCRP certification preferred.Skills and experience:
      • Knowledge of medical terminology and diseases preferred.
      • Excellent computer skills.
      • Ability to multi-task with strong organizational and prioritization skills.
      • Strong attention to detail. ? Customer focused personality.
      • Clinical Research Experience (minimum of 2 years, 5 years preferred)Working knowledge of IRB and regulatory processes and systems
      • Current knowledge of Federal regulations including Food and Drug Administration (FDA), Good Clinical Practice (GCP), National Institute of Health (NIH), Department of Health and Human Services (DHHS); International Conference on Harmonization Good Clinical Practice (ICH GCP) and study protocols.MINIMUM PHYSICAL REQUIREMENTSOCCASIONALLY
        • 1-33% OF TIME (0.5 TO 2.5 HOURS)Bend/twist
        • Squat/kneel
        • Reaching above shoulder
        • Driving FREQUENTLY 34-66% OF TIME (2.6 TO 5.0 HOURS)
        • Standing
        • Walking
        • Sitting
        • Lifting/carrying up to 30 lbs.Pushing/pulling up to 50 lbs. may need assistance CONTINUOUSLY 67-100% OF TIME (5.1 TO 12 HOURS OR GREATER)
        • Flexing/extending of neck
        • Hand use: grasping, gripping, turning
        • Repetitive hand/arm use
        • Computer skills Audible speech
        • Hearing acuity
        • Depth perception
        • Peripheral vision
        • Seeing-far/near Problem solving
        • Decision making Interpreting data
        • The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. EOE M/F/Disability/VetRequisition ID: 2022-36261 External Company Name: Nationwide Children's Hospital External Company URL: Street: 700 Children's Dr

Keywords: Nationwide Children's Hospital, Columbus , Senior Research Regulatory Coordinator - Research Translational, Other , Columbus, Ohio

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