Clinical Studies Coordinator - Surgical Oncology Research

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report’s 2017 rankings. It is one of only 49 comprehensive cancer centers designated by the National Cancer Institute.

The primary purpose of the clinical studies coordinator position is to provide administrative and patient care services for the coordination of clinical trials. The clinical studies coordinator will assist in the preparation of information, reports, and logs for clinical research protocols.

Develops and maintains a processing and tracking system for all protocol related paperwork. Participates in the development of policies, procedures, and work flow processes to ensure project efficiency and effectiveness. Participates in protocol start-up meetings and close out visits. Assists in analysis and quality assurance of clinical research information. Responsible for tracking and recording deviations, violations, adverse events and other study related activities. Reads protocol and develops systems for screening and scheduling patients. Develops on-study notes and other documents as needed for protocols. Responsible for accurate and timely transcription of study data to paper and/or electronic Case Report Form (CRF), retrieving information from electronic record, chart, and/or phone call. Requires ability to gather relevant information and determine the appropriate information to report. Responsible for scheduling labs, tracking return visit time points per protocol, tracing and recording. Establishes a system for tracking, processing, and monitoring the research program operations and protocols that are utilizing the services of the biorepository. Participates and contributes to the institutional and external compliance efforts necessary for the clinical trials and laboratory processes. Performs the patient care related duties of the clinical trial including: In consultation with the physician, assesses patients for eligibility through personal interviews and medical record review. Responsible for accurate and successful patient recruitment to assigned protocols. Assists in or obtains informed consent. Follows patients on studies and maintains knowledge of adverse events.  Also, submits information on adverse events to IRB and revises consents. Orders and tracks protocol related labs, responses and research tests. Schedules patient tests, keeping patients informed about test results and studies. Collaborate with lead or referring physicians, mid-level practitioners, and research nurses and data managers to document patient care. Responsible for tracking and recording deviations, violations, adverse events and other study related activities.

Coordinates protocol development, implementation and completion to ensure regulatory compliance with federal, state and local laws and policies related to institution and department programs, with minimal oversight from the PI, manager and/or director. Collaborates as well as works independently conducting minimal risk studies according to FDA and ICH guidelines of Good Clinical Practice. Applies research knowledge in the effective management of research protocols. Documents and organizes protocol related items consistent with protocol guidelines, institutional and departmental policies, Good Clinical Practice and Federal Regulations. Directly communicates and ensures approval from primary investigators prior to implementation of new or existing protocols. Responsible for obtaining, maintaining, monitoring, and ensuring safety compliance for IRB required training and safety compliance for laboratory. Orders laboratory supplies as needed for assigned protocols. Demonstrates knowledge of the current NCI-common Toxicity criteria and Institutional Reporting requirements. Assess and records all adverse events and serious adverse events. Submits External Safety Reports to the Office of Protocol Research/IRB within the required timelines.

SALARY RANGE