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Title:  Research Administration Associate- Regulatory Affairs

Division:  Surgery
Schedule:  Monday - Friday; 8:00 am - 5:00 pm
Work Location:  Texas Medical Center, Houston, TX
Salary Range:  $55,779-$68,500
FLSA Status:  Exempt
Requisition ID:  3107
Job Purpose

The Office of Surgical Research within the Michael E. DeBakey Department of Surgery is seeking a skilled Research Administration Associate to assume responsibilities of daily activities on a portfolio of research protocols which include securing and maintaining IRB approvals, tracking and reporting of relevant information and materials in specified systems and ensuring safety of research participants. 

Job Duties
  • Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review.
  • Coordinate the planning, preparation, data collection, assembly, review and publication of regulatory submissions to the FDA and other government agencies. 
  • Reports and responds to agencies inquiries or comments. 
  • Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies. 
  • Prepares regulatory reports and coordinate data collection and reporting with other departments. 
  • Tracks changes in regulatory guidelines and develops new guidance as they may occur within the Office of Clinical Research SOPs regarding federal regulations, institutional policies, and ICH GCP guidelines.
  • Maintains working knowledge of regulatory changes through guidelines, articles, writings and courses. 
  • Prepares updates on laws, regulations, standard operating procedures (SOPs) and guidelines for distribution to appropriate study personnel and investigators.
  • Supports Principal Investigators and study staff by assisting in the data collection and notification required for reporting of Adverse Events.
  • Facilitates communication with IRB related to Adverse Events. Supports study monitoring, as needed and requested. 
  • Assists with regulatory affairs training. 
  • Provides CTMS training to clinical research staff, and aids IT in system development.
  • Assists in routine QA review of active research protocols, and timely resolution of findings.
  • Facilitates discussions to streamline review of clinical research protocols, administrative applications for us of hospital facilities, and investigator and institutional conflicts of interest.
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.

 3107

CA