Job Description

This position provides and coordinates clinical care for research subjects. It plays a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation, and accuracy of data collection, data recording and follow‑up. The role also engages in study procedures including administration of investigational drugs, detailed clinical assessments with adverse event evaluations, and performing laboratory tests. Additional nursing care may be required in response to participant reactions to the study intervention. The position is responsible for study coordination and data management, focusing on subject recruitment and enrollment, consistency of study implementation, data integrity, compliance with regulatory and institutional requirements, and reporting. It will support the Principal Investigator and Research team for departmental studies under minimal supervision. Position Duties Provides nursing care to research study patients, including: Performing and/or scheduling medical tests within the scope of nursing licensure (laboratory tests, vital sign readings, imaging studies, cardiac and/or pulmonary function tests, and psychological evaluations). Administering study medications and performing patient assessments during clinic visits to determine presence of side effects; notifying the principal investigator and responding to findings/issues. Providing patient education and medical information to study patients and their families to ensure understanding of proper medication dosage, administration and disease treatment. Documenting medical data in patient chart to ensure availability of 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 implementation of appropriate methods, practices, and procedures for all research activities in designated area. Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis. Maintains compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors. With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants. Coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met. Coordinates the process for opening new studies, including: Obtaining needed background material on proposed research projects and presenting findings to the attending physician/principal investigator. Completing feasibility questionnaires. Circulating the confidentiality disclosure and trial agreements to the appropriate parties. Creating study budgets and working with management to determine financial feasibility and resources necessary to conduct the trial. Developing workflow procedures for the study team based on the specific protocol. Completes all tasks required by study sponsors, including: Providing regulatory documents to the sponsor in a timely manner. Completing case report forms, data entry, and maintaining source documentation for all study participants. Tracking and reporting adverse events per sponsor and institutional guidelines. Coordinating research monitor visits and responding to all data queries. Participates in recruitment and selection of study participants, coordinating and participating in research subject informed consent and entry into appropriate research studies while ensuring that all inclusion and exclusion criteria are met. Reviews monthly financial reports, including study participant billing, expenditures, and revenue; maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment for continuous operational efficiency. Participates in a variety of professional development programs to ensure ongoing awareness and understanding of current methodologies, practices, and philosophies as applied to the relevant patient population and research area. Performs miscellaneous job‑related duties as requested. Position Qualifications Education: Associate’s degree (ADN) or Bachelor’s degree (BSN) in nursing – Required. Preferred: Bachelor's Degree in Nursing. Experience: Two years bedside/clinical nursing experience – Required. Preferred: One or more years clinical research experience. Special Skills: Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care – Required. Licensure & Certifications: Current State of Arizona RN License or an RN license from a compact state with multi‑state privileges or the ability to establish licensure according to Arizona law prior to start date – Required. Current BLS Certification for Healthcare Provider from the American Heart Association – Required. Clinical Research Training Certification – Preferred. ACRP or SOCRA Clinical Research Certification – Preferred. Physical Requirements & Occupational Exposure/Risk: Physical Requirement – Feeling (sensing textures and temperatures) – Frequently. Physical Requirement – Fine Motor Skills (pinching, gripping, etc) – Frequently. Physical Requirement – Hearing – Frequently. Physical Requirement – Pushing/pulling – Occasionally. Physical Requirement – Reaching – Occasionally. Physical Requirement – Sitting – Frequently. Physical Requirement – Standing – Frequently. Physical Requirement – Stooping/crouching/kneeling/crawling – Occasionally. Physical Requirement – Talking – Frequently. Physical Requirement – Tasting/smelling – Occasionally. Physical Requirement – Walking – Frequently. Physical Requirement – Near Vision – Constantly. Physical Requirement – Color Discrimination – Occasionally. Physical Requirement – Use of keyboard, mouse and/or computer equipment – Constantly. Physical Requirement – Lift up to 35 pounds without assistance – Occasionally. Occupational Exposure – Inside office environment – Applicable. Occupational Exposure – Airborne communicable diseases – Applicable. Occupational Exposure – Bloodborne pathogens or bodily fluid – Applicable. Occupational Exposure – Fumes or airborne particles – Applicable. #J-18808-Ljbffr Phoenix Children's Hospital, Inc.

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