[Remote] Research Projects Specialist, Senior

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Note: The job is a remote job and is open to candidates in USA. Nemours Children's Health is an internationally recognized children’s health system, and they are seeking a Research Projects Specialist, Senior to facilitate all clinical and translational research activities. The role involves supporting research studies, managing data, and overseeing program activities while ensuring compliance with research protocols.


Responsibilities

  • Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned
  • Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
  • Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements
  • Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner
  • Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance
  • Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
  • Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
  • Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
  • Coordinates monitoring activities with Sponsor’s representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS
  • Participates in continuous process improvement initiatives and implementation of outcomes
  • Prepares for internal and external audits. Prepares corrective action plans as indicated

Skills

  • Bachelor's degree required
  • At least 5 years experience with clinical and translational research projects
  • Master's degree preferred

Company Overview

  • Nemours Children's Health is committed to improving the health of children. It was founded in 1936, and is headquartered in Jacksonville, Florida, USA, with a workforce of 5001-10000 employees. Its website is http://www.nemours.org.

    • Company H1B Sponsorship

  • Nemours Children's Health has a track record of offering H1B sponsorships, with 2 in 2023, 1 in 2022, 4 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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