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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 for assigned protocols; addresses data entry omissions or inconsistencies in a timely manner Assists in database coordination, to include quality checks, build, and maintenance for all IIT/IND studies that are utilizing an institutional database and sponsor selected studies Responsible for special projects as assigned by Research Nurse Manager of Compliance & Quality Assurance Assist in education and training efforts of newly onboarded staff to include 1:1 trainings and group trainings/presentations 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, toxicity, and other 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]) Ensure CORE/OnCore is kept up to date for trials within the department 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 Prepares reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, quarterly, semiannually, and annually) Assist in preparation of protocol close out visits and termination of trials as neededCLINICAL 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 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 Create templates for database builds works with the PI, DMI developers, database coordinator to ensure capture of all elements to prove/disprove objectives of the study Initiate institutional request for research purposes with Epic, CORe, PDOL, and other data entry and data integration systems 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 appropriatelySr. Research Data Coordinator - Data QualityDATA COMPLIANCE & QUALITY ASSURANCE & IMPROVEMENT: Coordinates and participates in monitoring visits and internal or external audits to ensure objectives are met Assist with quality assurance/improvement initiatives Lead on audit coordination as assigned Assist in preparation of site for scheduled audits 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 all trials particularly non-monitored trials and trials identified as at risk Formally report out findings of quality checks in group settingADMINISTRATIVE 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 Create and run reports on trial accrual for active protocols to assist research nurse manager and others in assigning protocols, determining work load, and initiating closure and warehousing of studies 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 Assist in creation of Data Coordination Manual/SOPs/Workflows Creates, maintains, and provides status reports to departmental contracts and budgets team members to help facilitate appropriate study payment Trains staff and others on data management, data entry, tracking, databases, and other tasks as needed Designs, implements, and reports on projects and project status 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 warehousingOther duties as assignedHigh school diploma or equivalent. Preferred Education: Bachelor's degree Four 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.htmlAdditional InformationRequisition ID: 152246
Employment Status: Full-Time
Employee Status: Regular
FLSA: non-exempt, eligible for overtime, and is subject to the provisions of the Fair Labor Standards Act (FLSA)
Work Week: Days
Fund Type: Soft
Work Location: Hybrid Onsite/Remote
Pivotal Position: No
Minimum Salary: US Dollar (USD) 39,500
Midpoint Salary: US Dollar (USD) 49,500
Maximum Salary : US Dollar (USD) 59,500
Science Jobs: No
Full-time