Senior Coordinator, Research Data

Summary

The primary purpose of the Sr. Coordinator, Research Data position is to

Support GI Clinical Research Administration with the regulatory, safety and quality assurance aspects of research protocols. Impacts the clinical research program efficiency and productivity and supports the Manager, Clinical Protocol Administration.

The ideal candidate will have previous experience with regulatory, clinical research, and knowledge of ICH- Good Clinical Practice.

Key Functions

  • Supports the GI Medical Oncology Regulatory Safety team. Primary responsibilities include the processing of safety reports (SUSARs/INDSRs) for GIMO clinical trials.
  • Submission of safety reports to the Institutional Review Board (IRB) as required
  • Coordinate and ensure timely review and processing of safety reports as per department, institutional and sponsor policies and regulations.
  • Acts as a liaison with industry pharmaceutical companies and CROs to retrieve safety information for GIMO clinical trials.
  • Manage SUSAR tracking system for all safety reports for GIMO clinical trials
  • Liaise with the research administration and central offices;
  • Assist with the submission research protocols to institutional committees and regulatory bodies
  • Coordinate and maintain various regulatory documents in accordance with institutional policies, ICH-GCP, FDA regulations and department SOPs.
  • Perform quality assurance (QA) reviews intermittently as directed supervisor, PI, or management.
  • Attend weekly/monthly research meetings and provide feedback on status of assigned tasks during meetings.
  • Create and maintain standard operating procedures (SOPs) and team workflow materials.
  • Develops and maintains a processing and tracking system for research trial information.
  • Independently gathers pertinent information by reviewing various files and documents.
  • Collaborates with physicians, nurses and other disciplines on assigned tasks.
  • Maintains adequate knowledge of clinical trials, such as methodologies and regulations, including, but not limited to attending seminars, reading publication materials, manuals, manuscripts and reports as needed.
  • Maintains an up-to-date and accurate status report and creates summary reports as requested for supervisor, PI, and/or management.
  • Determines work priorities, meets deadlines, adheres to departmental policies, independently able to solve problems promptly and applies correct solutions.
  • Assist with coordination of departmental and research review meetings.
  • Assist with processing of internal Serious Adverse Events (SAEs).
  • Assist in special projects as assigned.


  • 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

    Additional Information
    • Requisition ID: 142681
    • 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
    • Pivotal Position: No
    • Minimum Salary: US Dollar (USD) 38,000
    • Midpoint Salary: US Dollar (USD) 47,500
    • Maximum Salary : US Dollar (USD) 57,000
    • Science Jobs: No