Clinical Trials Nursing Specialist
1 week ago
Role: Clinical Research Nurse
Department: RSRCH-GRNT | Nephrology Research Studies
Location: Phoenix
This role is pivotal in delivering and managing clinical care for participants involved in research studies. The Clinical Research Nurse is essential in ensuring the safety of participants, maintaining informed consent, upholding the integrity of study protocols, and ensuring accurate data collection and follow-up.
Key Responsibilities- Patient Care:
- Administers nursing care to research participants, including scheduling and performing medical tests within nursing licensure.
- Administers investigational medications and conducts patient assessments during visits to monitor for side effects, promptly notifying the principal investigator of any findings.
- Educates patients and their families about medication usage and disease management to ensure comprehension.
- Maintains accurate documentation in patient records to support timely decision-making.
- Regulatory Compliance:
- Ensures that all assigned studies adhere to FDA, OHRP, and GCP guidelines.
- Completes and submits necessary documentation to IRB and institutional committees as required.
- Maintains up-to-date regulatory binders as mandated by regulations and sponsors.
- Collaborates with the principal investigator to explain study objectives and requirements to participants.
- Facilitates informed consent processes and ensures participant eligibility based on inclusion and exclusion criteria.
- Study Coordination:
- Initiates the process for new studies by gathering background information and presenting findings to the principal investigator.
- Completes feasibility assessments and manages confidentiality agreements.
- Develops study budgets and collaborates with management to assess financial feasibility.
- Establishes workflow procedures for the study team based on specific protocols.
- Sponsor Relations:
- Submits regulatory documents to sponsors in a timely manner.
- Completes case report forms and maintains source documentation for all participants.
- Monitors and reports adverse events in accordance with sponsor and institutional guidelines.
- Coordinates visits from research monitors and addresses all data inquiries.
- Participant Recruitment:
- Engages in the recruitment and selection of study participants, ensuring compliance with inclusion and exclusion criteria.
- Financial Oversight:
- Reviews financial reports related to study participant billing and expenditures.
- Maintains inventory levels of supplies and equipment, initiating requisitions as necessary.
- Professional Development:
- Participates in ongoing professional development to stay informed about current methodologies and practices relevant to the research area.
Mission: To advance hope, healing, and the best healthcare for children and their families.
Vision: To be the leading pediatric health system in the Southwest, recognized for exceptional care, innovative research, and advanced medical education.
Values: We prioritize children and families, deliver exceptional care, collaborate for greater impact, set standards for pediatric healthcare, and ensure quality care is accessible and affordable.
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