Research Data Coordinator

Location
Houston, Texas
Salary
Competitive
Posted
April 28 2021
Ref
139508
Organization Type
Healthcare/Hospital
The primary purpose of the Research Data Coordinator position is to assist in the daily activities of complex head and neck cancer clinical research through collaboration with multiple investigators, research nurses, patients, pharmacists, pathologists, radiologists, surgeons and other allied health care personnel.
The Research Data Coordinator adheres to Federal regulations, State and local laws relating to research, Institutional and IRB policies and procedures, and Good Clinical Practice (GCP) guidelines.

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
-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 assigned studies that are utilizing an institutional database
-Responsible for special projects as assigned by Research Nurse Manager, Associate Director of Research Planning and Development and PI.
-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, CORe, PDOL, and the EHR (OneConnect [Epic])
-Records data specific deviations to deviation logs as indicated by sponsor request and other governing entities
-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)

Clinical Trials Coordination
- Proactively screens for potential patients that may participate in head and neck trials.
- Provides the informed consent to the patients and participates in the informed consent process.
- Completes all protocol specific documentation in a timely manner.
-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
-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

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
-Coordinates and participates in monitoring visits and internal or external audits to ensure objectives are met
-Assists on assigned protocol audits; participate on site audits
-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

Education Required:
High school diploma or equivalent.

Education Preferred
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

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