Regulatory Affairs Associate

Job description

Summary The Regulatory Affairs Associate works to support the Protocol Office and investigators associated with 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 a detailed understanding of clinical research and applicable regulations. The accuracy and timeliness of the submissions for these protocols is crucial to ensure that our center remains in compliance and maintains a positive relationship with various study sponsors and national organizations that fund our hematology and oncology studies. This position is essential to ensure that all these studies remain active and in good standing with IRBs and other regulatory agencies. Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay. Job Duties: - Coo...