Research Nurse 2 – Pediatric Oncology (Hybrid)

Responsibilities

• Ensure the safety of study participants, and maintain communication with their families/caregivers and clinicians.
• Provide clinical and administrative nursing support and oversight for research clinical trials based on scope of practice.
• Collaborate with clinical staff, researchers, outside vendors, and other staff to administer treatment and study protocols.
• May coordinate multi-site studies.
• Develop and manage budget for research study, and oversee resources including funds, personnel, and equipment as needed.
• Collaborate with principal investigator to review study protocol and assess and analyze feasibility, budget projections, and staffing needs.
• Conduct study participant evaluations according to the study protocol, assess adverse events, and apply triage and judgment to determine course of action.
• Oversee and potentially administer medications and treatments per study protocol for out study participant research participants.
• Comply with institutional policies, standard operating procedures, and guidelines, and prepare and submit documentation as required by the study protocol, study sponsor, and regulatory authorities.
• Interpret complex protocols and regulatory requirements.
• Oversee and manage essential regulatory documents and handle confidential information (verbal and written) with tact and diplomacy, adhering to all HIPAA guidelines.
• Supervise non-clinical research staff as needed.
• Identify, recruit, and enroll study participants, as well as maintain study participant records and determine study participant criteria.
• Host external audits (Food and Drug Administration, National Institutes of Health, etc.).
• Support sponsor investigator research with Investigational New Drug/Investigational Device Exemption applications.

Qualifications

• Pediatric Oncology experience highly desired (Pediatric or neonatal nursing experience acceptable).
• Experience in clinical research.
• Experience with EMR system (EPIC).