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Clinical Research Nurse

University of Minnesota School of Nursing

Position Details Department: PCH-MAIN | Magnet Program Location: Phoenix Shift: Mon-Fri, Days, 8am-5pm Category: Research Posting #: 1016089 Employee Type: Full-Time Position Summary This position provides and coordinates clinical care for research subjects. It plays a central role in assuring participant safety, maintaining informed consent, ensuring protocol integrity, and accurate data collection, recording and follow‑up. The role engages in study procedures including administration of investigational drugs, performing detailed clinical assessments and adverse event monitoring, and conducting laboratory tests. Additional nursing care may be required based on participant response to the study intervention. The position leads study coordination and data management, focusing on participant recruitment and enrollment, consistency of study implementation, data integrity, and compliance with regulatory and institutional requirements and reporting. The duties support the Principal Investigator and research team for departmental studies under minimal supervision. Position Duties Provides nursing care to research study patients, including: Performs and/or schedules medical tests within the scope of nursing licensure, including laboratory tests, vital sign readings, imaging studies, cardiac/pulmonary function tests, and psychological evaluations. Administers study medications and performs patient assessments during clinic visits to detect side effects; notifies the principal investigator and responds to findings/issues. Provides patient education and medical information to study patients and their families to ensure understanding of medication dosage, administration, and disease treatment. Documents medical data in patient charts to ensure timely records for decision making. Ensures assigned studies are conducted in accordance with FDA, OHRP, and GCP guidelines, including: Reviews all regulatory requirements to ensure appropriate methods, practices, and procedures are implemented for all research activities. Manages the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis. Maintains up‑to‑date compliance documentation in regulatory binders per regulations and sponsor requirements. With the principal investigator, explains the study purpose, parameters, and requirements to participants. Coordinates research subject informed consent and study entry, ensuring all inclusion and exclusion criteria are met. Coordinates the process for opening new studies: Obtains background material on proposed research projects and presents findings to the attending physician/principal investigator. Completes feasibility questionnaires. Circulates confidentiality disclosures and trial agreements to the appropriate parties. Creates study budgets and works with management to assess financial feasibility and resource needs. Develops workflow procedures for the study team based on specific protocol. Completes all tasks required by study sponsors: Provides regulatory documents to sponsors in a timely manner. Completes case report forms, data entry, and maintains source documentation for all study participants. Tracks and reports adverse events per sponsor and institutional guidelines. Coordinates research monitor visits and responds to all data queries. Participates in recruitment and selection of study participants, coordinating and executing informed consent and ensuring inclusion/exclusion criteria are met. Reviews monthly financial reports, including participant billing, expenditures, and revenue; maintains inventory levels of supplies and equipment, initiates requisitions, and ensures continuous operational efficiency. Participates in professional development programs to stay current with methodologies, practices, and philosophies relevant to the patient population and research area. Performs miscellaneous job‑related duties as requested. #J-18808-Ljbffr

Vacancy posted 4 days ago
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