Clinical Research Nurse Specialist I, RN

5 days ago

Cleveland, Ohio, United States University Hospitals Full time
Job Summary

University Hospitals seeks a skilled Clinical Research Nurse Specialist I, RN to join our team. As a key member of our research team, you will be responsible for providing safe and efficient age-specific nursing care to patients/families using the nursing process in combination with clinical research protocol requirements.

Key Responsibilities
  • Coordinate and implement assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines.
  • Responsible for submission of related documents to the appropriate research review committees and maintenance of regulatory documentation.
  • Perform day-to-day activities related to clinical research studies, including recruit and screens participants, obtain informed consent, educate participants regarding study requirements, and complete source documents and case report forms (CRFs).
  • Conduct nursing assessments of research participants, including appropriate reporting.
  • Document, record, and assimilate accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP), and internal and external regulatory agencies.
  • Establish and maintain communications with Investigator, Sponsor, and internal constituents.
Requirements
  • BSN (Bachelor's Degree in Nursing) required.
  • 2+ years of clinical experience in patient care required.
  • Clinical research experience preferred.
  • Experience in a team setting preferred.
Preferred Qualifications
  • Ability to prioritize the work of multiple projects.
  • Knowledge of GCP and FDA guidelines.
  • Detail-oriented person with the ability to collect, compile, and analyze information.
  • Ability to understand and communicate research protocol requirements to others.
  • Able to work independently on multiple tasks and manage time effectively.
  • Medical terminology.
  • Effective verbal, written, and communication skills.
  • Computer skills: Excel, Access, and Word.
  • Travel may be required.
Licenses and Certifications
  • Registered Nurse (RN) in the State of Ohio required.
  • Certification in Human Subjects Protection (CITI) Good Clinical Practices, HIPAA, and CITI Training required.
  • Basic Life Support (BLS) required.
  • OH Driver's License (Valid) with car insurance coverage required.

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