Clinical Research Nurse I, Clinical Research Management Organization - Georgetown University Medica
Clinical Research Nurse I, Clinical Research Management Organization - Georgetown University Medical Center
Georgetown's Clinical Research Management Office (CRMO) provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. This includes all regulatory documents, IRB submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on Lombardi website, design of electronic case report forms for institutional trials.
The Clinical Research Nurse I serves as research nurse for clinical trials using investigational agents for the hematology/oncology group. S/he is responsible for patient safety, data management, and protocol compliance, and acts as a liaison with staff, IRB, physicians, pharmaceutical companies, and federal agencies requiring data. Reporting to the CRMO Nursing Manager, the Clinical Research Nurse I has duties that include but are not limited to:
- Ascertains study patient eligibility for clinical trial.
- Supports and evaluates patient adherence to protocol and documents any deviations.
- Assesses, identifies, and prioritizes clinical information for medical team for patients that are enrolled on clinical trials.
- Assists in the assessment, management and coordination of care across the continuum of care (outpatient, inpatient and home), including triage of phone calls, symptom management and proactive patient communication.
- Maintains patient safety and protocol compliance.
- Reports and documents serious adverse events per protocol and institutional policy.
- Provides patient education about clinical trial treatment, possible side effects, and required testing.
- Administers financial management for patients participating in clinical trials.
- Schedules in-service for appropriate staff regarding clinical trial.
- Coordinates with protocol office regarding regulatory affairs.
- Collaborates with data management for patients enrolled in clinical trials.
- Assists with collection and documentation of eligibility, randomization, patient assessments, treatments, and follow-up care as defined in the protocol.
- Ensures that all documentation is completed in an accurate and timely manner.
- Prepares and participates in site initiation visits, monitoring visits, and audit visits.
- Provides information to regulatory bodies.
- Bachelor's in Nursing
- Current DC licensure as a registered nurse
- 3 years - preferably 5 years - of experience - preferably in oncology
- BLS certification
- Computer proficiency preferred
- Research experience preferred
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