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Title:  Research Regulatory Affairs Associate

Division:  Office of Research
Schedule:  Monday - Friday, 8 a.m - 5 p.m
Work Location:  Texas Medical Center, Houston, TX
Salary Range:  Up to $56,650
FLSA Status:  Exempt
Requisition ID:  2033
Summary

Internal Title:  Research Administration Associate

External Title:  Research Regulatory Affairs Associate

 

This position is within the Office of Clinical Research (OCR), which falls under the umbrella of the Baylor Office of Research. Provides analytical and regulatory support for OCR supported clinical trials, with a focus mainly on liver studies. The individual must be a self-directed, flexible, conscientious and detail-oriented professional who can quickly adapt to a variety of situations.

Job Duties
  • Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review. Coordinate 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 and develops new guidance as they may occur within the Office of Clinical Research SOPs regarding federal regulations, institutional policies, and ICH GCP guidelines.

 

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  • Maintains working knowledge of regulatory changes through guidelines, articles, writings and courses.
  • Prepares updates on laws, regulations and guidelines for distribution to appropriate study personnel and investigators.
  • 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.
  • Provides CTMS training to clinical research staff, and aids IT in system development.
  • Assists in routine QA review of active research protocols, and timely resolution of findings.
  • Facilitates discussions to streamline review of clinical research protocols, administrative applications for us of hospital facilities, and investigator and institutional conflicts of interest.
Minimum Qualifications

·         Required: Bachelor's degree.

·         Required: Two years of relevant experience.

 

 

 

 

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

 2033