- 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 Clinical Research Manager, Program Manager 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)
- Proactively screens for potential patients that may participate in head and neck trials.
- 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 offsite 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 studyrelated 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
- 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 closeout/termination
- Maintain adequate supplies for research record storage
- Prepare terminated trials for warehousing
- Requisition ID: 166563
- Employment Status:
- Employee Status:
- Work Week:
- Minimum Salary:
- Midpoint Salary:
- Maximum Salary :
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Coordinator, Research Data - Houston, United States - MD Anderson Cancer Center
Description
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 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
KEY FUNCTIONS
Data management
Clinical Trials Coordination
Administrative Activities
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.
FLSA:
non-exempt and eligible for overtime pay
Fund Type:
Soft
Work Location:
Hybrid Onsite/Remote
Pivotal Position:
No
Referral Bonus Available?:
No
Relocation Assistance Available?:
No
Science Jobs:
No
\#LI-Hybrid
