Regulatory Affairs Associate - Medicine - Administration (90002353)

Baylor College of Medicine

Houston, TX

Job posting number: #7080334 (Ref:7358-en_US)

Posted: June 23, 2021

Application Deadline: Open Until Filled

Job Description

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 



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.


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