Coordinator, Research Data - Thoracic-Head & Neck Med Onc

MISSION STATEMENT
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. 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 2022-2023 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute

JOB SPECIFIC COMPETENCIES

DATA MANAGEMENT
•Abstracts and collects patient data from electronic health record and other relevant source documents
•Ensures high quality data management, including tracking receipt, QA, and entry of patient data; entering
protocol data into the appropriate database(s) and generating queries for missing or incorrect data
•Issue nursing/CSC/PI queries, tracks query return, and follow-up on all delinquent requests
•Performs ongoing and concurrent review of data to ensure completeness and accuracy; addresses data
entry omissions or inconsistencies and amend errors in a timely manner
•Assists in database coordination, build, and maintenance for all IIT/IND studies that are utilizing an
institutional database
•Responsible for special projects as assigned by Research Nurse Manager of Data Compliance & Quality
Assurance
•Develops and maintains systems for controlling data flow; develops spreadsheets or other tracking tools for
data that cannot be entered into a database
•Provides data for study progress and patient safety reports, such as IRB continuing reviews and IND reports
•Creates accrual and/or toxicity reports as needed; assists in the collection and evaluation of protocol data
and compiles protocol data for statistical review/manuscript submission
•Utilizes different institutional databases to obtain and verify patient and protocol information including, but
not limited to, PDMS, CORe, PDOL, and the EHR (OneConnect [Epic])
•Records data specific deviations to deviation logs as indicated by sponsor request and other governing
entities
•Assist research staff with creation of new user accounts and database support on assigned studies
•Follows and adheres to national/state, institutional, departmental, and sponsor guidelines to accomplish and
complete daily work assignments
•Prepare protocols for close out visits and termination

CLINICAL TRIALS COORDINATION
•Consults with principal investigator and other department personnel verbally, in handwritten
notes or via keyboard on computer regarding ongoing studies; requires ability to gather information and
determine the appropriate information to report.
•Participates in protocol site initiation/logistics meetings and attends departmental or
institutional research meetings as well as approved off-site meetings or conferences
•Processes requests for protocol specific shipments of materials (supplies, specimens, etc.) and
investigational agents.
•Submit request for image upload to sponsor vendor entities and follow-up as necessary
•Coordinate/communicate frequently with other 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 or violations.
•Develop templates/processes through communication with other research staff to ensure all
information needed for data capture is documented.
•Inform research staff and others on upcoming deadlines to ensure data is completed
•Acts as a liaison between the research team, sponsor, CROs, other institutions, and agencies to
ensure data is captured accurately and appropriately.

ADMINISTRATIVE ACTIVITIES
•Maintains a level of professional expertise and credibility through attendance at both
institutional and outside continuing education programs to keep current with research changes in regulations and
policy.
•Tracks and manages all relevant protocol paperwork and essential documents in accordance with
uirements and institutional policies and procedures.
•Demonstrates excellent oral and written communication skills when contacting other
institutions and agencies (i.e., NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, computer-
generated reports/emails and/or face to face.
•Coordinates and participates in monitoring visits and internal or external audits to ensure
objectives are met.
•Review CD/Zip files of completed data points for preparation of study close-out/termination
•Maintain adequate supplies for research record storage.
•Prepare terminated trials for warehousing.

Other duties as assigned

Education Required - High school diploma or equivalent.

Preferred degree: Bachelor's degree

Experience Required - Two years of related experience. With preferred degree, no experience required.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html