Position Summary
The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and is the only one in Alabama and in the Deep South region. A comprehensive designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival. On-campus and around Birmingham, the O'Neal Cancer Center is a significant part of our economic powerhouse. The O'Neal Cancer Center powers more than 400 scientists and physician-scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care. The link to our website is: https://www.uab.edu/onealcancercenter/
To collect data and enter it in accordance with established procedures. To perform routine analyses and prepare reports in the prescribed format. To provide data management support.
Duties and Responsibilities
- Provides principal investigators and the Oncology clinical trials operational teams with adequate specialized data collection to ensure that statistical information and results from clinical trials are captured and recorded accurately.
- Maintain the accuracy, integrity, and security of complex, large pharmaceutical databases.
- Works independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects.
- Accurately captures, in a timely manner, subject information into various study-specific data capture systems (electronic and paper).
- Requires knowledge of various disease states and the ability to determine the appropriate clinical information to report.
- Information reviewed may include, but is not limited to treatment records, clinical and radiographic evaluations, diagnostic test results, records of surgery, and pathology information.
- Supports principal investigators and the clinical trials operational team with administrative, data collection, and entry in the management to support the day-to-day execution of clinical trials from start-up to closeout.
- Ensures adherence to compliance with established SOPs, GCP, IRB, FDA, and other applicable regulatory requirements in the execution of clinical trials.
- Utilizes systems for controlling the data flow for clinical trials.
- Obtains required forms, slides, reports, and other pertinent information required for subject eligibility analysis.
- Assists in the analysis and quality assurance of clinical trial research information.
- Coordinates routine monitoring and audits with industry sponsor pharmaceutical representatives or clinical research organizations.
- Coordinates the preparation of data for audits and monitoring visits.
- Provides sufficient, appropriate, and timely responses to sponsor verbal and written queries.
- Attends protocol-specific training including but not limited to Study Investigator's Meeting, Study Initiation, and Study Startup.
- Participates in conference calls and/or meetings with vendors.
- Attends approved off-site meetings and conferences.
- Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the clinical trial process, including but not limited to eligibility and disease processes.
- Attends weekly CTO meetings, participates in training and educational opportunities.
- Assists assigned disease team(s) with FDA audits, and serve as a liaison between investigators and pharmaceutical sponsors.
- Adheres to protocol data collection as related to billing activities to maintain clinical trial timely data reporting, to resolve and answer data queries from sponsors, perform data analysis, document verification for protocol compliance and drug accountability prior to research data capture, and coordinate preparation of data for audits and monitoring visits.
- Performs other duties as assigned.
Hourly Pay Range: $17.95 - $29.20
