Clinical Research Nurse Specialist I - II Hybrid Work Arrangement

University Hospitals   Cleveland Heights, OH   Full-time
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Provide safe and efficient age-specific nursing care to patients/families using the nursing process in combination with clinical research protocol requirements. The department to support is within GI Hepatology.

  • Works in collaboration with the Principal Investigator to 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.
  • Performs 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).
  • Conducts nursing assessments of research participants including appropriate reporting.
  • Documents, records and assimilates 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.

Provide safe and efficient age-specific nursing care to patients/families using the nursing process in combination with clinical research protocol requirements. The department to support is within GI Hepatology.

  • Works in collaboration with the Principal Investigator to 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.
  • Performs 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).
  • Conducts nursing assessments of research participants including appropriate reporting.
  • Documents, records and assimilates 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.

  • Bachelor Degree in Nursing, BSN RN - Registered Nurse 2+ years of clinical exp in patient care required & 1-3 yrs clinical research experience (adv degree may offset exp).
  • DOT/IATA Training (must be obtained within 30 days of hire). Certification in Human Subjects Protection, Good Clinical Practices, HIPAA, and CITI Training (must be obtained within 30 days of hire). CPR/BLS Certification (must be obtained within 30 days of hire).
  • Valid Drivers License/Required Car Insurance Coverage.
  • Nursing Specialty Certification (does not include BLS, ACLS, PALS, TNCC, or NRP) or Research Certification (ACRP or SoCRA).
  • Ability to prioritize the work of multiple projects.
  • Experience in a team setting desirable. Knowledge of GCP and FDA guidelines.
  • Travel may be required.

This job is no longer available.

University Hospitals

Cleveland Heights, OH