Title:  Regulatory Affairs Specialist

Division:  Obstetrics and Gynecology
Schedule:  Monday - Friday; 8:00 a.m.- 5:00 p.m.
Work Location:  Houston, TX
Salary Range:  $46,176 - $63,723
FLSA Status:  Exempt
Requisition ID:  12377

Summary

The Fetal Center Research team works in collaboration with Texas Children's Hospital Pavilion for Women. Our main focus is on fetal intervention clinical trials. We are seeking a full-time Regulatory Affairs Specialist to work on FDA regulated sponsor-investigator trials and multi-center collaborative research projects. We are looking for someone who can work in a fast-paced multi-disciplinary environment and is detailed oriented. The primary role of the Regulatory Affairs Specialist is to oversee regulatory and administrative requirements for conducting research and provide guidance in the accumulation of regulatory documentation.

Job Duties

  • Prepares and develops protocol documents and consent forms.
  • Compiles and maintains regulatory documentation databases or systems.
  • Coordinates efforts associated with the preparation of regulatory documents for FDA and IRB submissions.
  • Communicates with FDA, IRB and PIs related to submissions, renewals and adverse events.
  • Coordinates, prepares, or reviews regulatory submissions for domestic or international projects.
  • Interprets regulatory rules or rule changes and ensures they are communicated through policies and procedures.
  • Escorts government inspectors while on site and provides post-inspection follow-up information as requested.
  • Coordinates with other departments for regulatory documentation and submissions as needed on interdisciplinary interdepartmental research studies.
  • Prepare outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.
  • Assists in preparing initial IDE/IND submissions, supplements, amendments, and annual reports for FDA sponsor investigator trials.

Minimum Qualifications

  • High School diploma or GED.
  • Four years of relevant experience.

Preferred Qualifications

  • Bachelor's degree in a related field.
  • Certification: CCRP, CRA, CRC, RAC, etc.
  • Self-directed, independent and organized.
  • Requires effective communication skills, both orally and in writing.
  • Experience with complex protocols and regulatory submissions desired (FDA submission experience preferred).
  • Requires interpersonal skills necessary to coordinate regulatory documentation and submissions between a multi-disciplinary research team.

 

 

Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

 

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

 12377

CA; SN