Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist supports the investigators and clinical research operations associated with The Texas Children's Cancer and Hematology Centers (TXCH), covering a significant portion of Phase 1 protocols and protocols from prolific consortia. This position ensures regulatory compliance for a specified portfolio of over 80 studies, including reviewing protocols, submitting protocols to regulatory agencies, and navigating approval processes.

Responsibilities

• Follow SOPs and coordinate regulatory correspondence across internal stakeholders and external institutions
• Prepare protocol documents and required regulatory forms for institutional and regulatory agency approval
• Maintain and expand understanding of federal regulations, ICH GCP guidelines, and internal SOPs
• Act as a liaison between institutional review committees, regulatory agencies, and investigators to ensure protocol approvals and compliance
• Ensure distribution of appropriate information between investigators, regulatory agencies, and staff involved in research projects
• Maintain regulatory databases and systems, electronic and paper study files, and keep the study team and supervisor informed of protocol-related issues
• Work proactively and collaboratively with other team members to streamline work and achieve mutual goals

Requirements

• High School diploma or GED and four years of relevant experience
• Ability to serve as a resource to clinical investigators and staff
• Ability to manage shifting priorities in short time frames
• Excellent oral and written communication skills
• Knowledge of medical/scientific terminology preferred
• Excellent organization skills and ability to multi-task
• Strong computer skills, including Microsoft Office Suite

Qualifications

• Bachelor’s degree (no experience required with Bachelor’s degree)
• Two or more years of experience in regulatory affairs and/or clinical research at an academic medical center or hospital
• Certification in Clinical Research, SOCRA, or other preferred
• Knowledge and understanding of clinical research compliance, including OHRP, FDA, and other federal regulations and requirements

Skills

• Knowledge of clinical research and/or regulatory processes and applicable federal regulations and ICH GCP guidelines
• High sense of professional behavior and conduct and ability to communicate with various levels of faculty and staff