Within the UI Stead Family Department of Pediatrics, Division of Neonatology, the clinical research nurse will apply clinical and administrative skills in carrying out clinical research protocols. The clinical research nurse will be involved in all aspects of research including patient recruitment and enrollment, patient education and assessment, data collection and monitoring, collection and processing of biological samples, regulatory documentation, reviewing case report forms, assisting in protocol evaluation, and coordinating scheduling of follow-up appointments. The successful applicant will work with the entire research team on all research protocols.
Duties to include:
- 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.
Education Requirements
- Bachelor's degree in nursing or a combination of an Associate's degree in nursing and relevant experience.
- 6 months to 1 year previous clinical experience.
- A Current, valid Iowa Registered Nurse license.
- Proficiency with Microsoft Office and the Internet.
- Excellent written and verbal communication skills.
- 1-3 years previous experience and participation with clinical trials.
- 1-3 years previous experience in a role requiring independent decision making.
- Experience working in a Neonatal Intensive Care Unit.
- Knowledge of IRB guidelines and procedures.
In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission:
- Resume
- Cover Letter
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.
For additional questions, please contact pedsuichildrenshr@healthcare.uiowa.edu
This position is not eligible for University sponsorship for employment authorization.
Additional Information
- Classification Title: Clinical/HC Research Assistant
- Appointment Type: Professional and Scientific
- Schedule: Full-time
- Work Modality Options: On Campus
- Pay Level: 4A
- Organization: Healthcare
- Contact Name: Natasha Johnson
- Contact Email: pedsuichildrenshr@healthcare.uiowa.edu
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