The Clinical Research Nurse coordinates all aspects of multiple oncology and/or hematology clinical trials. Clinical trials include Phase I-II trials under locally held INDs, as well as Phase II/III industry sponsored trials. This requires multidisciplinary skills directed towards clinical patient management and safety, protocol administration, providing education and training to research staff, clinical staff, medical providers, patients and their families.
Incumbents at this level know fundamental concepts, practices and procedures; resolve readily identifiable problems; and utilize the nursing process and standards to perform protocol-specific procedures, prevent or manage research subjects’ participation in all clinical research settings.
- Administers medications and treatments, as defined by study protocol.
- Conducts, coordinates and serves as a resource for various aspects of clinical trials from start-up to closeout according to study protocols.
- Contributes to study start-up activities, including site initiation visits, document template creation, study staff training, and clinical in-services.
- Patient recruitment, screening, consent, enrollment and necessary registrations.
- Provides education to staff, subjects and families about protocols, treatment, possible side effects and complications.
- Performs study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records and personal communications with other healthcare workers.
- Assists research team with routine quality control checks.
- Assist with study close-out activities as directed.
- Completes and submits required documentation to regulatory agencies. Identifies and assesses defined adverse events and reports to appropriate parties. May be done in collaboration with a Regulatory Specialist.
- Participates in production of research publications or presentation of research data.
*These factors are used to determine the complexity of a clinical trial: Level of Disease, Level of Acuity, Independence Level of Thinking/Knowledge Level, Level of Supervision