MD Anderson Cancer Center Jobs

SUMMARY

The primary purpose of the Coordinator Research Data (Head & Neck) position is to assist in the development of and helps maintain a system for controlling paper flow for protocols and dissemination of data resulting from the protocols, for the completion of data forms, treatment records and review of records before submission to pharmaceutical companies, federal agencies, internal groups, and other institutions. Assists in the coordination of communication between these groups and department physicians regarding research studies.

The Head and Neck section of the Thoracic/Head and Neck Medical Oncology department treats patients with cancers in the oral cavity, pharynx, larynx, salivary glands, paranasal sinuses and nasal cavity. Our goals are to provide the highest quality of care to our patients and to advance the treatment of head and neck cancers. Our physician team includes 8 physicians, including 2 physician scientists. We conduct broad Phase I, II and III studies which involve many of the most promising molecularly targeted agents, novel immunotherapies, and combinations of agents currently known. We also collaborate closely with other teams in the Head and Neck Center, including surgery and radiation oncology.

JOB SPECIFIC COMPETENCIES

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; 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])

•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

•Prepare protocols for close out visits and termination

CLINICAL 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

•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.

•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.

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

uirements 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.

•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

High school diploma or equivalent. Preferred degree: Bachelor's degree 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

Additional Information

• Requisition ID: 149191

• 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) 34,500

• Midpoint Salary: US Dollar (USD) 43,000

• Maximum Salary : US Dollar (USD) 51,500

• Science Jobs: No