first_imgSummaryThe Senior Regulatory Affairs Associate works to support theProtocol Office and investigators associated with The TexasChildren’s Cancer and Hematology Centers (TXCH). As a SeniorRegulatory Affairs Associate in Regulatory Affairs, multi-faceted,complex pediatric oncology treatment protocols will be assigned.The role is expected to interface with other academic centers, NIHfunded consortia, the National Cancer Institute, the Federal DrugAdministration (FDA), and industry sponsors on highly sensitive andconfidential projects. This position supports all aspects ofregulatory compliance for a specified portfolio of clinical trials.This support includes, but is not limited to, reviewing protocolsand protocol related documents, submitting protocols to regulatoryagencies and review committees and ensuring successful navigationof approval processes for clinical research. This position requiresexpertise and understanding of clinical research and applicableregulations.This position will be assigned the more complex BMT and cellulartherapy studies within the Pediatric Hematology and Oncology Centerat BCM.This position requires onsite work and does not offer 100% remotework option.Job DutiesApplies a detailed understanding of federal and internationalregulatory requirement when preparing regulatory reviewapplications.Assists and advises Investigators on their compliance withfederal and international regulation acquirements, obligations andresponsibilities that govern the conduct of clinical researchstudies.Assigned studies in pediatric oncology and hematology humansubjects research with an emphasis on IND trials.Coordinates regulatory correspondence across internalstakeholders and external institutions. Prepares protocol documentsand required regulatory forms in order to obtain institutional andregulatory agency approval for the conduct of clinical researchprojects at the TXCH.Assists with training junior staff under the guidance of theDirector of Regulatory Affairs. Baylor College of Medicine is an Equal Opportunity/AffirmativeAction/Equal Access Employer.5632CA; CH Preferred QualificationsFour or more years of experience in regulatory affairs forclinical research at an academic medical center or hospital withknowledge of clinical research practices and regulations.Regulatory Affairs Certificationcenter_img Minimum QualificationsBachelor’s degree.Four years of relevant experience.last_img