Research Data Specialist

Research Data Specialist

K EY F UNCTIONS

D ATA M ANAGEMENT :

· 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 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])

· Ensure CORE 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)

· Prepare protocols for close out visits and termination

C LINICAL T RIALS C OORDINATION :

· 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

· 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 appropriately

D ATA C OMPLIANCE & Q UALITY A SSURANCE & I MPROVEMENT :

· 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 setting

A DMINISTRATIVE A CTIVITIES :

· 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

· Back-up for monitor assist on assigned trials

· 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 warehousing

Other duties as assigned.

Education Required: Bachelor's degree in a related field.

Preferred education: Master's degree in a related field. With preferred degree, no experience required.

Experience Required: Two years research study experience. May substitute required education degree with additional years of equivalent experience.

Experience Preferred: Six years of research data experience. Quality / Compliance experience related to clinical research.

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