Senior Clinical Research Coordinator, Clinical Research Management Organization - Georgetown Univer
Senior Clinical Research Coordinator, 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 Senior Research Coordinator supports phase I, II and III clinical trials using investigational agents for the solid tumor or hematology disease groups in responsibilities that include patient safety, data management, and protocol compliance. Reporting to the CRMO Nursing Manager, the Senior Research Coordinator has duties that include but are not limited to:
Clinical Trials Administration
- 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 who 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.
- Ensures that all pre-study laboratory/medical tests are completed, eligibility requirements are completed.
- Arranges pre/post procedure laboratory/medical tests.
- 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 CRCs.
- 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.
- Documents and reports serious adverse events per protocol and institutional policy.
- Compiles and analyzes data.
- Prepares for and participates in 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, National Cancer Institute (NCI), Office of Human Research Protection (OHRP) and/or I International Conference on Harmonisation Good Clinical Practices (ICH GCPs).
- Bachelor's degree
- BLS certification
- 3 years related oncology and research experience
- Knowledge of clinical research, computer applications, and research process
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