Georgetown Univerisity Senior Clinical Research Coordinator, Clinical Research Management Office - Georgetown University Medical Center in Washington, District Of Columbia
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Senior Clinical Research Coordinator, Clinical Research Management Office - Georgetown University Medical Center
The Senior Clinical Research Coordinator administers phase I, II and III clinical trials using investigational agents for the solid tumor or hematology disease groups. Incumbent will be responsible for patient safety, data management, and protocol compliance. Acts as an expert liaison with staff, IRB, physicians, pharmaceutical 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. Participates in site initiation visits, monitoring visits, and audits. Incumbent will be responsible for financial management for patients participating in clinical trials. The coordinator 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. 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. 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. Will assist with projects for the CRMO i.e. SOP; s as necessary. Responsible for maintaining patient information in the CTMS. 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:
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.
Collaborates with members of the interdisciplinary team to develop and implement plan of care for the patient. Maintains patient safety and protocol compliance.
Collaborates with data management for patients enrolled in clinical trials. Enters data as assigned. Maintains patient information in the CTMS.
Assists with collection and documentation of eligibility, randomization, patient assessments, and treatments and follow up care as defined in the protocol. Ensures that all documentation is completed in a timely, complete manner.
Ensures that laboratory and tissue testing is completed and stored appropriately.
Assists with data and regulatory as necessary.
Assures appropriate billing for clinical trial and insurance. Follows study budget and enters visits in CTMS.
Participating and preparing for monitoring/audit visits. Provides information to regulatory bodies.
Serves as an expert in the clinical trial process from initiation through end of study. Maintains compliance of the protocol and follows FDA, NCI, OHRP and/or ICH GCP’s.
Ensures that all pre-study laboratory/medical tests are completed, eligibility requirements are completed. Arranges pre/post procedure laboratory/medical tests. Schedules tests as necessary. Assures appropriate billing for procedures.
Provides education to staff as applicable regarding clinical trials.
Serves as point person and lead for assigned clinical trials. Mentors and trains and reviews the work of entry level CRC’s.
Reporting and documenting serious adverse events per protocol and institutional policy.
Compile and analyze data.
Bachelor’s Degree, and BLS certification
Minimum of 3 years related oncology and research experience is preferred
Knowledge of clinical research, computer applications, and research process is preferred
Research certification preferred
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