Regulatory Affairs Specialist

Baylor College of Medicine

Houston, TX

ID: 7115686 (Ref.No. 13666-en_US)
Posted: November 9, 2022
Application Deadline: Open Until Filled

Job Description


The regulatory Affairs specialist works to provide centralized support within  the Office of Clinical Research (OCR) to multiple Principal Investigators (PIs) across the College and its affiliates. The position supports all aspects of regulatory compliance for both therapeutic drug and device trials in varying disease areas with multiple departments. 
The candidate will be located at McNair Campus and work alongside the Principle Investigators and research team. The ideal candidate will be self-motivated, organized and detail oriented. This is a full-time position, generally working within normal business hours of Monday-Friday, 8am-5pm.

Job Duties

  • Coordinates efforts associated with the preparation of regulatory start-up and ongoing clinical trials documents.
  • Communicates with Central and local IRBs, CROs,Sponsors and PIs related to new protocols and protocol amendments are submitted appropriately and continuing reviews are submitted in a timely manner.
  • Compiles and maintains regulatory documentation electronically and investigator site file.
  • Coordinates, prepares, or reviews regulatory submissions for Central IRBs, BCM IRB and affiliates.
  • Works closely with study team, research staff and PI's to ensure that all regulatory documents for research studies are up-to-date so as to streamline work and achieve mutual goals. 
  • Keeps the research study team and Manager informed of protocol related issues.
  • Facilitates communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
  • Coordinates and submit timely responses to CRO's,Sponsors, Central and BCM IRB, PI's inquiries.
  • Maintains study regulatory database, OCR regulatory database as applicable.

Minimum Qualifications

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

Preferred Qualifications

  • Bachelor’s degree. No experience required with Bachelor’s degree.



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.



Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. - Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective. - Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve. - Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.