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Title:  Regulatory Affairs Associate

Division:  Medicine
Schedule:  Monday - Friday, 8 am to 5 pm
Work Location:  Houston, TX
Salary Range:  $55,779 - $72,514
FLSA Status:  Exempt
Requisition ID:  7358

Summary

The Department of Medicine at Baylor College of Medicine is seeking an experienced, reliable, and enthusiastic Regulatory Affairs Associate under the department's newly established Clinical Trials Administration Unit to support investigators who are interested in starting a new clinical trial study by prioritizing studies through systematic assessment using scientific data available, reviewing and coordinating the regulatory and administrative requirements for conducting research; provides guidance in the accumulation of regulatory documentation. This person will work alongside other members of the clinical trial administration unit and department research administration team to ensure a successful trial is established.

Job Duties

  • Works with financial analyst, PI to assess budgetary needs on clinical trial studies (protocol reviews). 
  • Manages clinical study regulatory work for research studies or clinical trials. 
  • Assists with regulatory affairs training. 
  • Assists with IND/IDE submission and reporting to the FDA and other government agencies. 
  • Submits study protocols in the institutional online portal (BRAIN and CTA system). 
  • Communicates with IRBs and PIs related to submissions, renewals, and adverse events. 
  • Serves as the main contact for investigators, sponsors, government agencies, and the IRB. 
  • Supports daily operations for a research study or clinical trial.
  • Recruits, screens, and enrolls study participants; ensures participant adherence to study protocol. 

Minimum Qualifications

  • Bachelor's degree.
  • Two years of relevant experience.

Preferred Qualifications

  • Bachelor's degree in Biological Sciences, Health Sciences, etc. 
  • Prior experience in Regulatory or Clinical Trials.
  • Good communication/inter-person skills, accountable, organized, self-motivated, team player, works well under pressure, multitasking.

 

 

 

 

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

 7358

CA