Research Nurse - Leukemia

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public. 

KEY FUNCTIONS 

Protocol Management:  

Under supervision of the protocol primary investigator (PI) and the research nurse manager/supervisor assists the investigator in the overall conduction of the clinical trials assigned.  Assesses patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.  On a real-time basis, assesses the patient’s clinical status as per protocol requirements by coordinating, evaluating and following the patient’s participation in clinical trials including collaborating with the entire medical care team as necessary, assisting protocol serious adverse events (SAE) reporting, participating in Quality Assurance (QA) procedure for reporting and monitoring Serious Adverse Events.  Provides documentation in the patient’s medical record, protocol specific documents, and institutional requirements.  Communicates availability of protocol treatments for accrual.  Maintains the institutional patient regulatory protocol requirements (deviation logs, SAEs, AE logs, IRB continuing review, etc.).  Participates in monitoring, audit activities, SIVs, conference calls, interim assessments, protocol meetings, and email/written business correspondence.  Ensures that the conduction of assigned studies is in accordance with Good Clinical Practice, Federal regulations and institutional policies.  Notifies clinical and/or research laboratories of protocol-required laboratory tests including EKGs, PKs, PDs, urine collection, etc.  Prepare orders for protocol-related tests, procedures, consults, requests for pathology slides and blocks as needed.  Communicates verbally and in writing with primary investigator, other protocol managers, clinical staff to ensure protocol patient safety and protocol compliance.  Conveys information clearly, accurately and concisely through both formal and informal communication.  Provides coverage for other protocol managers.  Informs appropriate staff and arrange coverage for necessary functions when absent.  Work in situations involving uncertainty, shifting priorities, and rapid change; deal constructively with mistakes and setbacks; demonstrate flexibility. 

Protocol Data:

Assists the primary investigator in collection and evaluation of data.  Oversees protocol-related data documentation in the medical record.  Collaborates with data entry staff to ensure data is accurately entered into required database or on a handwritten case report form.  Reviews patient response to treatment, treatment toxicities and adverse drug reactions with the principal investigator.  Reports to the Institutional Review Board and the study sponsor.  Provides protocol summary reports as requested. 

Patient Education and Professional Education: 

Identifies patient and family educational needs regarding treatment management, evaluation and follow-up in clinical trials through talking with patients person-to-person or by telephone and provides appropriate education and/or educational materials.  Ensures human subjects protection in accordance with federal, state and institutional requirements.  Facilitates the patient’s provision of initial informed consent and re-consent.  Addresses research participants’ inquiries and concerns.  Provides professional and ancillary staff education concerning research protocols by preparing in-service materials and performing protocol in-service as needed.  Provides accurate information as requested to the multidisciplinary team.  Keeps current concerning oncology and research study management issues through reading and or attending meetings/in-services.