Job Abstract

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 2021-2022 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

KEY FUNCTIONS

1. Participates in the coordination of correspondence/protocol administration for departmental clinical research.

· Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., Surveillance Committee) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration).

· Reviews patients for eligibility of potential protocols and assist in obtaining consent.

· Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination.

· Assist in coordinating and send outgoing material and correspondence to institutional, state, and/or federal agencies.

· Prepare reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, semiannually, and annually).

· Inform sponsors and collaborators of regulatory status of protocols

· Collect specimens as outlined in assigned protocols.

· Maintain a system for controlling paper flow for protocols and related grants, to include setting up and maintaining reference file system.

· Maintain and update protocol reference materials.

· Assist in the preparation of scheduled status reports describing interim data, using CORE and/or any other databases (e.g. RedCap, Sponsor eCRF).

2. To assist research nurses and other clinical research personnel with patient-related activities.

· Obtain outside films, surgical pathology, and lab reports as required by protocol.

· Submit specimens/films for reading.

· Order protocol laboratory supplies, including tubes, air bills, and shipping supplies.

· Maintain adequate supply of protocol-related treatment forms.

· Coordinates the acquisition of research blood or tissue specimens correctly and in a timely fashion and transport to appropriate locations, as specified by protocols.

· Prepare tissue specimens correctly, as specified by protocols.

· Follow up on lab/translational data collection, processing, and compilation.

3. Data entry, analysis, and reporting.

· Develop and maintain databases for collection of research data.

· Transfer patient information into the electronic database and act as lead for ensuring maintenance of accurate data entry.

· Retrieve protocol information via computer and visual chart reviews and by communicating directly with both internal and external healthcare providers to schedule and procure testing and treatment records. Obtain outside films, surgical, pathology, and lab reports as needed. Submit specimens/films for reading.

· Review medical records to extract data points.

· Perform data entry into database and casebooks and statistical analysis programs.

· Collect and enter data into case report forms (CRFs).

· Assist with data analysis.

· Make survival calls and appropriately record the data.

· Maintain accurate and up-to-date patient flowsheet, to include entry of toxicities, adverse events, follow-up visits, dose modifications, and any other protocol-required data.

· Generate data reports, protocol summary reports, and user-generated data reports, as requested.

· Provide support for data and information related to protocols, grants, abstracts, and manuscript submissions, as needed. Assist in writing abstracts, manuscripts, grants, and correspondence.

· Maintain schedules for timely submission of grant data.

4. Professional expertise and credibility through educational programs/training and mentoring of new staff.

· Attend department research meetings and conferences.

· Attend approved off-site meetings and conferences.

· Supplement education as needed through use of reference materials, lectures, etc.

· Be punctual in arriving at all professional functions.

· Inform appropriate staff and arrange coverage for necessary functions when absent.

· Assist in the training and mentoring of new clinical trials staff in regard to department policies and procedures for the conduct of clinical trials and the appropriate completion of data entry.

· Initiates self-audits

5. Organizational system for research meetings, deadlines.

· Generate documents on computer, using word processing, spreadsheet, and other software to produce professional appearance.

· Assist in the coordination and preparation of a monthly update for protocol review.

· Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.

· Understand and adhere to the policies and procedures related to conduct of clinical trials.

· Schedule monitor visits in department, CTRC and Pharmacy. Enter approval for monitors in EPIC.

Other duties as assigned.