Location: Houston, TX
Cap-Exempt H-1B Position — No lottery required
## **Summary** The Regulatory Affairs Associate works to support the Protocol Office and investigators associated with Baylor College of Medicine Department of Pediatrics at The Texas Children's Cancer and Hematology Centers (TXCH). This position supports all aspects of regulatory compliance for a specified portfolio of clinical trials. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. This position requires expertise and understanding of clinical research and applicable regulations. Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay. ## **Job Duties** - Coordinates regulatory correspondence across internal stakeholders and external institutions. - Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects at the TXCH. - Maintains and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs. - Maintains working knowledge of regulatory requirements through independent continuing education using guidelines, articles, and courses. - Develops and maintains positive relationships with institutional review committees and sponsor through oral and written communications. - Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained. - Facilitates investigators in reporting and responding to institutional review committees' and other regulatory agencies' inquiries or comments. - Provide