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Research
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GI Medical Oncology 231100
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142354 Requisition #
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Summary

The primary purpose of the Senior Research Data Coordinator position is to provide administrative and patient care services for the coordination of clinical research studies for the Department of Gastrointestinal Medical Oncology.  Act as a lead in the development of protocol specific databases.  Act as a preceptor for research data coordinators, Assist with abstracts, manuscripts and correspondence specific to investigator initiated studies.   Coordinates studies sponsored by drug companies and the FDA.  Collaborate with investigators regarding study requirements and progress.  Develop interdepartmental relationships resulting in procedures specific to protocol implementation. 

 

Key Functions

  1. Data/ Protocol Management:  Coordinates communication between the research nursing staff and protocol patients by conducting weekly phone calls to protocol patients, assisting with scheduling of protocol related tests and appointments.  Verifies schedules with patients for accuracy and timeliness.  May be involved in research collection and accurate logging in database.  Maintains a level of professional expertise and credibility through continuing education programs as shown by conference and class attendance records.  Participates in formal and informal instruction of professional nurses and other healthcare professionals regarding clinical research trials, and attends sectional conferences, outside conferences and workshops, computer classes within the institution as required.  

 

  1. Data Collection:  Coordinates and maintains systems for data collections for protocols and non-protocol studies as evidenced by observation of supervisor.  Established files/records can be easily be found by others.  Computerizes files for tracking purposes.  Visually reviews data for correctness and edits as necessary with RN oversight.     

 

  1. Audit Preparation:  Assist Research Nurses with all research audits.  Visually reviews data for correctness and edits as necessary with RN oversight.  Visually reviews information to be filed in order to classify, files and purge information.  Maintains schedules for timely submission of data to the funding sources and internal review committee.  Develops and organizes protocol binders for active protocols.

 

  1. Monitor Visits:  Coordinates monitor visits, assists with startup meetings and is responsible for preparation of all case report forms completion prior to monitor visits.  Accurately perform corrections to case report forms with oversight by RN.

 

  1. Transcribing Data:  Accurately transcribes research data into the case report forms with five or less errors per page.  Ensures that all adverse events, concomitant medications are transcribed accurately.  Obtains outside medical records on protocol patients from various institutions and verifies all records are readable, accurate, and complete.  Reviews all outside lab results for accuracy and completeness as specified by the protocol.  Establishes a system for maintaining all CLIA certifications and lab logs for protocols.

 

  1. Trains other support staff in study coordination to include providing training and guidance with regard to the policies and procedures related to clinical trial audits.

 

  1. Obtains outside pathology slides or request pathology slides within the institution following institutional guidelines and policies. Registered protocols on tissue station as required by institutional policy.  Collects research blood samples and research tissue per protocol.  Mails research tissue samples to designated sponsor or certified lab per protocol using the proper procedures for Shipping and Handling of Infectious and Biological materials.

 

  1. Performs research charge capturing which includes submitting research charges to GIMO research finance personnel within 24-48 hours of procedure or tests performed.  Verifies research procedures are ordered per protocol and coded as standard of care or covered by the research as outlined in the protocol coverage analysis.

 

  1. Other duties as assigned.

 

MARGINAL OR PERIODIC FUNCTIONS:

  • Other duties as assigned.
  • This position will require a person who is motivated and willing to learn new skills.
  • Represent department in a professional and appropriate manner within the institution, as well as externally.
  • Must also be able to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds.
  • Requires use of typewriter and computer via keyboard, and operating facsimile machine, calculator, printer, photocopy machine, etc. Requires the use of push-button, multiple line telephone set. Master new software by utilizing available resources (other department personnel, reference manual, taking classes, etc.
  • Must be able to use all office equipment as noted above. Read and understand printed and written data in English.
  • The performance for all expected outcomes is measured by observation by supervisor, reports from physicians and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress.

 

High 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.html

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