Clinical Research Coordinator, Clinical Research Management Office - Georgetown University Medical
Clinical Research Coordinator, Clinical Research Management Office - Georgetown University Medical Center
Georgetown University Clinical Research Management Office (CRMO), a shared institutional resource of the Lombardi Comprehensive Cancer Center (LCCC), provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. This includes all regulatory documents, Institutional Review Board 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 the Lombardi website, and design of electronic case report forms for institutional trials.
The Clinical Research Coordinator manages patient safety, data management, and protocol compliance for phase I, II and III clinical trials using investigational agents for the solid tumor disease groups. Reporting to the Supervisor of Research Nursing, the Clinical Research Coordinator has duties that include but are not limited to:
- Collaborates with investigators to determine trial eligibility, maintain protocol integrity, and manage data collection.
- Supports and evaluates patient adherence to protocol and safety, and documents any deviations.
- Assesses, identifies and prioritizes clinical information for medical team for patients 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 education and communication.
- Prepares for and participates in site initiation visits, monitoring visits, and audits.
- Serves as liaison with staff, IRB, physicians, pharmaceutical companies, and federal agencies requiring data.
- Schedules in-service for appropriate staff regarding clinical trial.
- Administers financial management for patients participating in clinical trials.
- Collaborates with data management for clinical trials patients to assure that the documentation for the clinical trial is accurately completed in a timely manner.
- Coordinates with protocol office regarding regulatory affairs.
- Bachelor's degree
- Basic Life Support (BLS) certification
- Preference for at least 3 years of related oncology and research experience
- Preference for knowledge of clinical research, computer applications, and research process
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