Senior Research Data Coordinator - Gynecologic Oncology

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

Protocol Patient Management   

Assumes responsibility for multiple assigned minimal risk studies, identifies potential protocol candidates performs screening for eligibility and provides study specific information to them. Collaborates with other research team members and or study principal investigator (PI) regarding subject eligibility questions. Participates in the informed consent process and registers subjects utilizing the institutional clinical trial management system according to institutional policy. Documents study specific information appropriately in the patient medical record. Conducts semi-structured interviews with research subjects for protocol data collection. Administers questionnaires to eligible participants in the outpatient and inpatient setting. Coordinates with research staff to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting and protocol deviations. Develops and maintains a detailed screening log as well as patient tracking systems.  Assists with follow-up appointments and provides telephone reminders to patients. Interacts with members of interdisciplinary team inter and intra-departmentally to obtain pertinent information and verify the status of ongoing projects. Verbal, telephone, email and written communications are timely and intent is clearly communicated with institutional and other personnel. 

Research Data Management  

Maintains knowledge of protocol specific guidelines and general procedures for data management practices for research protocols.  Assists in the development and maintenance of a system for collecting protocol data.  Abstracts and collects patient data from electronic health record and other relevant source documents.  Obtains off-site treatment, surgery and pathology records as required by protocol. Enters research study data into electronic case report forms (CRFs) or local data systems as required, in accordance with protocol requirements and departmental timelines. Performs ongoing and concurrent review of data to ensure completeness and accuracy. Addresses data entry omissions or inconsistencies and amends errors in a timely manner.  Communicates research data revision requests to the physician and/or clinical research staff for correction. Trains other members of research staff on database utilization and management. Assists with data compilation for the preparation of information and reports for manuscript/grant submission.

Protocol Administration Responsibilities 

Ensures the conduct of assigned clinical trials is in accordance with Good Clinical Practice guidelines, federal regulations, institutional and departmental policies and procedures.  Reviews new protocols for data management requirements. Participates and/or assists in organizing Site Initiation Visits (SIVs), conference calls and protocol meetings. Assists with annual reviews, updates, and response data, and generates reports as requested.  Collaborates with PI, study team, and departmental protocol administration team to complete financial and regulatory tasks as assigned.  As appropriate orders supplies needed for study management. Attend departmental meetings, mandatory training, and/or other events to remain current of policies and procedures related to data and protocol management.

Other duties as assigned