Regulatory Affairs Coordinator - Duncan Cancer Center

Baylor College of Medicine

Houston, TX

ID: 7057828 (Ref.No. 310744JC)
Posted: June 14, 2019
Application Deadline: Open Until Filled

Job Description

Provides analytical and regulatory support to the clinical research support unit.

  • Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review.
  • Coordinates the planning, preparation, data collection, assembly, review and publication of regulatory submissions to the FDA and other government agencies.
  • Reports and responds to agencies inquiries or comments.
  • Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies.
  • Prepares regulatory reports and coordinate data collection and reporting with other departments. Tracks changes in regulatory guidelines as they may occur.
  • Prepares updates on laws, regulations and guidelines for distribution to appropriate study personnel and investigators.
  • Maintains working knowledge of regulatory changes through guidelines, articles, writings and courses.
  • Supports Principal Investigators and study staff by assisting in the data collection and notification required for reporting of Adverse Events.
  • Facilitates communication with IRB related to Adverse Events. Supports study monitoring, as needed and requested.
  • Assists with regulatory affairs training. 

Required:

  • Bachelor's degree in a related field.

Preferred:

  • Experience and working knowledge of federal regulations related to clinical trial research and IRB procedures.
  • Master's degree in a related field.
  • Regulatory Affairs Certification (RAC)




 

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