Clinical Research Nurse

4 weeks ago

Iowa City, Iowa, United States University of Iowa Hospitals & Clinics Full time
Job Summary

We are seeking a highly skilled Clinical Research Nurse to join our team at the UI Stead Family Department of Pediatrics, Division of Neonatology. The successful candidate will apply clinical and administrative skills in carrying out clinical research protocols, working closely with the research team to plan, develop, and implement research protocols.

Key Responsibilities
  • Perform clinical/health care research activities in a skilled/specialized area.
  • Organize clinic or study procedures and follow study participants and maintain records of their visits and interviews.
  • Administer assigned aspects of the various study components, including therapies and/or procedures with NICU patients, children, and mothers.
  • Disperse study-related medications per protocol.
  • Obtain and process human blood and tissue samples.
  • Serve as a liaison to the UIHC/University Business Office in identifying research tests and procedures by assisting with tracking enrollment and reconciling capitation from the Neonatal Research Network.
  • Assist with preparing and writing research progress reports and summary data for inclusion in various reports for analysis and for submission to NICHD or journals.
  • Serve as a member of the interdisciplinary clinical research team, working closely with the Research Manager to plan, develop, and implement research protocols.
  • Attend protocol meetings as required. Possess a thorough understanding of the protocols.
  • Enter patients on protocol, ensuring that all prerequisites have been completed and are within the required parameters.
  • Serve as a liaison to local physicians/hospitals to facilitate care of protocol participants when hospitalized at outside institutions.
  • Prepare and present educational materials for participants and other staff to carry out protocol therapy as needed.
  • Screen, recruit, enroll, and obtain informed consent for clinical research activities and perform skilled work in a specialized area of research.
  • Oversee the recruitment of subjects and scheduling of trial-related procedures.
  • Prepare study recruitment materials.
  • Develop complex study recruitment materials.
  • Explain the study to the participants' families and assist in obtaining consent to be enrolled in each protocol.
  • Counsel the participant and family regarding the intent of the studies.
  • Participate in the design; development, and testing of clinical research trial data systems.
  • Assist in determining the validity of data obtained from clinical studies.
  • Revise and implement change in data collection.
  • Responsible for collecting, assembling, and mailing data forms, bills, specimens, and other protocol-related documents and medical records.
  • Responsible for data entry into the NRN data base.
  • Communicate with Research Manager and PI about the status of the research projects.
  • Follow Federal Regulations related to human subjects' research and assist in maintaining regulatory documents.
  • Monitor compliance of regulatory guidelines and proper maintenance of documents. Follow universal precautions and general policies and procedures in accordance with university, collegiate, hospital, and federal guidelines.
  • Maintain skills and competencies related to special equipment, medications, and procedures common to the research subject population being studied (NICU patients).
  • Assist in the preparation of IRB forms and annual reviews.
  • May recommend corrective action for reportable events.
  • Instruct other staff regarding clinical research and methods employed in research studies as appropriate.
  • Maintain effective working relationships with faculty, staff, students, and the public.
  • May provide functional and/or administrative supervision.
  • Mentor new staff under direction.
  • Assist in budget development and management of resources/supplies for study.
  • Contribute to identification of increased cost/inefficient spending and cost containment measures.
  • Assist participants with questions related to billing for protocol treatment procedures.

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