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Requirements

Senior Clinical Research Coordinator, Clinical Research Management Office - Georgetown University Medical Center

The Senior Clinical Research Coordinator serves as senior research coordinator for phase I, II and Ill clinical trials using investigational agents for the solid tumor or hematology disease groups. Incumbent will be responsible for patient safety, data management, and protocol complianc e . S/he acts as an expert liaison with staff, IRB, physicians, pharmaceutic a l companies, and federal agencies requiring data. The incumbent schedules in-service for appropriate staff regarding clinical trial, provides patient education about clinical trial treatment, possible side effects, and required testing and participates in site initiation visits, monitoring visits, and audit s . Incumbent will be responsible for financial management for patients participating in clinical trials. The coordinator also 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. This individual collaborates with investigators to determine trial eligibility, maintain protocol integrity and manage data collection. The clinical research coordinator collaborates with data management to assure that the documentation for the clinical trial is complete and accurate and enters data as assigned. S/he coordinates with protocol office regarding regulatory affairs. As a senior clinical research coordinator, the incumbent will be responsible for mentoring entry level coordinators and assisting with the orientation process. S/he w i ll also assist with projects for the CRMO i.e. SOP's as necessary. Most have exceptional analytical skills to address complex and non-routine issues requiring the development of innovative solutions. Duties include but are not limited to:

• Responsible for maintaining patient information in the CTMS.
• Screens patients for clinical trials, ensuring patient eligibility. Maintains patient safety and protocol compliance.
• Collects and prepares data. Organizes data into case report forms, databases, ect. Assists physicians in completing flow-sheets in medical records and progress notes. Schedules audits with pharmaceutical sponsors and other agencies.
• Reports and documents serious adverse events. Documenting adverse events in patient CRF.
• Monitors, records and reports patient's condition and reaction to drugs and treatments to the appropriate physician/nurse.
• Ensures that all pre-study laboratory/medical tests are completed, eligibility requirements are completed. Arranges pre/post procedures laboratory/medical tests.

Requirements

• Bachelor's degree, and BLS certification
• A minimum of 3 ye a rs related oncology and research experience is preferred
• Knowledge of clinical research, computer applications, and research process is preferred
• Research certification preferred