Clinical Research Coordinator
Clinical Research Coordinator - Clinical Research Management Office (CRMO), GUMC
The Clinical Research Coordinator serves as research coordinator for phase II and III clinical trials using investigational agents for the solid tumor disease groups. Incumbent will be responsible for patient safety, data management, and protocol compliance. Acts as a 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. S/he 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. S/he collaborates with investigators to determine trial eligibility, maintain protocol integrity and manage data collection. The incumbent is responsible for collection of specimens required by protocol and sending them per protocol requirements. The clinical research coordinator collaborates with data management to assure that the documentation for the clinical trial is complete and accurate. The incumbent will be responsible for entering data on some of the clinical trials in a timely manner. Coordinates with protocol office regarding regulatory affairs. 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.
- 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 entry and regulatory as necessary.
- Participating and preparing for monitoring/audit visits. Provides information to regulatory bodies.
- Ensures that all pre-study laboratory/medical tests are completed, eligibility requirements are completed. Arranges pre/post procedure laboratory/medical tests. Ensures specimens are collected and sent per protocol requirements.
- Provides education to staff as applicable regarding clinical trials.
- Bachelor's degree, and BLS certification
- A minimum of 3 years related oncology and research experience is preferred
- Knowledge of clinical research, computer applications, and research process is preferred
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