Senior Data Analyst - Thoracic - Head & Neck Med Oncology

The mission of The University of Texas MD 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 ideal candidate for this position will have experience working with various databases (RedCap, Prometheus, or other databases), as well as possess a clinical background. Experience with clinical data obtained from medical records is also preferred. 

DATA MANAGEMENT AND DATABASE COORDINATION:

• Organize and coordinate database builds
• Assists in database coordination, build, and maintenance for all IIT/IND studies that are utilizing institutional databases
• Work to enhance existing systems builds to deliver optimal end user experience, increase accuracy, and strengthen reporting outputs.
• Develops and maintains systems for controlling data flow; develops spreadsheets or other tracking tools for data that cannot be entered into a database
• Build protocol projects and required data elements into RedCap, Prometheus, and other institutional databases.
• Lead database training to research staff to ensure efficient and accurate entry of data to IIT databases
• Ensures high quality data management, including tracking, and entering protocol data into the appropriate database(s) and generating queries for missing or incorrect data
• Manages database access, ensuring access is provided to indiviuals listed on the DOA and have the appropriate access assignment in the database.
• Ensures trial database access is revoked at study closure to promote compliance with the use of database during trial life cycle.
• Performs ongoing and concurrent review of data to ensure completeness and accuracy; addresses data entry omissions or inconsistencies with the study team
• Abstracts and collects patient data from electronic health record and other relevant source documents
• Issue queries, tracks query return, and follow-up on all delinquent requests
• 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])
• Follows and adheres to national/state, institutional, departmental, and sponsor guidelines to accomplish and complete daily work assignments
• Prepares reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, quarterly, semiannually, and annually)

DATA PREPARATION & ANALYSIS:

• Assist in preparation of study analysis
• Perform some basic statistical analysis for basic reporting study requirements
• Assist with monthly metrics to include workload reports
• Corresponds with data coordinators, nurses, study coordinators, and PIs to ensure appropriate and timely data capture
• Prepare data for submission of abstracts, publications, presentations, new drug applications, etc
• Work with CR Registration to complete data points needed for CT.gov end of study results submissions
• Assist in preparation of data for continuing reviews, annual reports, and toxicity summary reports
• Review/reevaluate databases throughout trial life to ensure build is meeting objectives of the trial. Initiate or suggest changes as necessary
• Performs ongoing and concurrent review of data to ensure completeness and accuracy of trials, particularly non-monitored trials and trials identified as at risk
• Formally report out analytical findings of data checks in a one to one or group setting

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 sponsor requirements 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
• 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
• Develops database manuals, workflows and SOPs to direct those utilizing the databases on proper entry of data
• Develop instructional tools and quick start guides for completing final reporting for CT.GOV
• Participates in protocol site initiation/logistics meetings and attends departmental or institutional research meetings as well as approved off-site meetings or conferences
• Coordinate/communicate frequently with other research staff to identify and address any study-related issues, including but not limited to inadequate or missing data elements
• 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
• Trains staff and others on data management, data entry, tracking, databases, and other tasks as needed
• Lead designs, implements, and reports on projects and project status
• Review CD/Zip files of completed data points for preparation of study close-out/termination

Other duties as assigned.