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Clinical Trials Nursing Specialist
2 months ago
Role: Clinical Research Nurse
Department: RSRCH-GRNT | Nephrology Research Studies
This role is pivotal in delivering and managing clinical care for participants involved in research studies. The Clinical Research Nurse is responsible for ensuring the safety of participants, maintaining informed consent, and upholding the integrity of research protocols while ensuring accurate data collection and follow-up.
Key Responsibilities- Patient Care: Provide comprehensive nursing care to research participants, which includes:
- Conducting and/or arranging medical tests as permitted by nursing licensure, such as laboratory tests, vital signs, imaging studies, and psychological evaluations.
- Administering study medications and performing assessments during clinic visits to monitor for side effects, promptly notifying the principal investigator of any findings.
- Educating patients and their families about medication dosages, administration, and treatment protocols to ensure clarity and understanding.
- Documenting medical information in patient records to maintain accurate and timely information for clinical decision-making.
- Regulatory Compliance: Ensure that all assigned studies adhere to FDA, OHRP, and GCP guidelines, including:
- Reviewing regulatory requirements to implement appropriate practices for all research activities.
- Completing and submitting necessary documents to the appropriate institutional review boards and committees.
- Maintaining accurate documentation in regulatory binders as mandated by regulations and sponsors.
- Collaborating with the principal investigator to communicate study objectives and requirements to participants.
- Facilitating informed consent processes and ensuring all eligibility criteria are met for study participation.
- Study Coordination: Oversee the initiation of new studies by:
- Gathering background information on proposed research projects and presenting findings to the principal investigator.
- Completing feasibility assessments.
- Circulating confidentiality agreements and trial contracts to relevant parties.
- Developing study budgets and collaborating with management to assess financial viability and resource needs.
- Creating workflow procedures for the study team based on specific protocols.
- Sponsor Collaboration: Fulfill all obligations required by study sponsors, including:
- Providing regulatory documents to sponsors in a timely manner.
- Completing case report forms, data entry, and maintaining source documentation for all participants.
- Tracking and reporting adverse events in accordance with sponsor and institutional guidelines.
- Coordinating visits from research monitors and addressing all data inquiries.
- Participant Recruitment: Engage in the recruitment and selection of study participants, ensuring informed consent and eligibility criteria are met.
- Financial Oversight: Review financial reports related to study participant billing, expenditures, and revenue. Maintain inventory levels of supplies and equipment, initiating requisitions as necessary.
- Professional Development: Participate in ongoing professional development programs to stay informed about current methodologies and practices relevant to the patient population and research area.
- Additional Duties: Perform miscellaneous job-related tasks as assigned.
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 nationally for exceptional care, innovative research, and advanced medical education.
Values: We prioritize children and families, deliver exceptional care, collaborate with partners, set high standards in pediatric healthcare, and ensure quality care is accessible and affordable.