Research Administration Associate - Pediatrics - Research Resources Office (90005902)

Baylor College of Medicine

Houston, TX

Job posting number: #7062210 (Ref:2148-en_US)

Posted: November 6, 2019

Application Deadline: Open Until Filled

Job Description

Summary

Coordinates activities and provides analytical and regulatory support to the Pediatrics Research Resources Office and the Section of Neurology to ensure regulatory goals and objectives of various clinical projects are accomplished within a specified timeframe.

Job Duties

 

  • Manages clinical study regulatory work for studies being conducted through the Pediatric Research Resources Office.
  • Applies a detailed understanding of federal and international regulatory requirements when preparing regulatory review applications
  • Assists and advises Investigators on their compliance with federal and international regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies
  • Manages and prepares regulatory documents for submission through Baylor's online submission network, Biomedical Research and Assurance Information Network (BRAIN)
  • Maintains complete regulatory records
  • Supports PIs and study staff by assisting in the data collection and notification required for reporting of Adverse Events
  • May assist with regulatory affairs training

 

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  • Tracks changes in regulatory guidelines as they may occur
  • Supports study monitoring, as needed and requested
  • Maintains positive relationships with Baylor IRB, study sponsors, and regulatory agencies
  • May assist with IND/IDE submission and reporting to the FDA
  • Assists with Quality Assurance Audits and any internal or external audit
  • Prepares regulatory reports and coordinate data collection and reporting with other departments
  • Facilitates communication with IRB and PIs related to submissions, renewals, and adverse events
  • Develops, implements, and maintains appropriate policies, procedures, and standards concerning projects
  • Maintains regulatory database
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.

 2148

CA; CH 





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