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Research Regulatory Specialist, Institute for Translational Science (Hybrid) in Galveston, Texas at University of Texas Medical Branch

NewIndustry: Education / Teaching / AdministrationEmployment Type: Full-Time
University of Texas Medical Branch
Galveston, Texas, 77555, United States
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Job Description

Research Regulatory Specialist, Institute for Translational Science (Hybrid)

EDUCATION & EXPERIENCE

Minimum Qualifications:

Preferred Qualifications:

  • Clinical Research Associate (CRA) Certification
  • Experience in the medical/healthcare industry

Job Description

Scope: This position interacts with organizational units spanning Research Regulations and Compliance (RRC), Research Administration (RA), school and departments, central UTMB administration, University of Texas System, State and Federal agencies, and accrediting organizations

Provide analytical, technical, and professional support to the Office of Research Integrity and Regulatory Affairs. (RIRA).

  • Serve as a regulatory expert regarding compliance with GCP and the Code of Federal Regulations regarding clinical research and other pertinent regulations
  • Troubleshoot clinical trials and activities.
  • May serve as subject matter expertise to Information Technology in support of business objectives and initiatives, especially as it relates to interfacing and supporting the regulatory data.
  • Report the status of the quality levels of staff, systems and production activities.
  • Evaluate quality events, incidents, queries, and complaints.
  • Monitor regulatory changes and remain current on quality standards, all related legislation and compliance issues
  • Ensure regulatory rules are communicated through corporate policies and procedures
  • Ensure that investigator, vendor, facility and system audits are conducted.
  • Assume a lead role for the preparation, conduct, and responses to regulatory agency.
  • Performs related duties as required.
  • Assist the individual in successfully performing the role

  • Applied understanding of any applicable regulations (e.g., Good Clinical Practice, FDA CFR, clinical research ethics, HIPAA, and patient privacy laws).
  • Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands. High attention to detail and accuracy.
  • Able to foster collaborative and constructive relationships with colleagues, faculty, and management of the university.
  • Exceptional organizational skills and a focus on results that ensures timely progress on execution priorities.
  • Standard office environment at UTMBs main campus or other study locations

    Commensurate with experience.


    Equal Employment Opportunity

    UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.

    Compensation

      Job Location

      Galveston, Texas, 77555, United States

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