Summary

The Senior Regulatory Affairs Associate works to support the Protocol Office and investigators associated with The Texas Children's Cancer and Hematology Center (TXCH). This position is a key member of the regulatory team and supports all aspects of regulatory compliance for a specified portfolio of clinical trials. This support includes, but is not limited to, planning, preparing, submitting, and maintaining regulatory submissions and approvals that support oncology and hematology clinical research. Reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. The Senior Regulatory Affairs Associate, supports a variety of research projects including multi-faceted, highly complex pediatric oncology or hematology protocols and investigator held INDs. The role is expected to interface with other academic centers, NIH funded consortia, the National Cancer Institute, the Federal Drug Administration (FDA), and industry sponsors on highly sensitive and confidential projects. 

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.

Job Duties

• Lead and/or support regulatory process for assigned pediatric oncology and hematology human subjects projects including the development, compilation, and submission of regulatory documents to IRBs/IECs, FDA, and other agencies (e.g., INDs, IDEs, 1572s, annual reports, protocol amendments, safety reports, continuing reviews, study closures).
• Conduct internal document reviews for completeness and accuracy (e.g. protocols, manual of operations, consent forms, recruitment materials).
• Coordinate and track initial and ongoing approvals for investigator‑initiated trials (IITs), sponsored trials, expanded access, and compassionate use programs.
• Coordinate regulatory correspondence across internal stakeholders and external institutions.
• Provide regulatory expertise during feasibility, start-up and the complete lifecycle of the assigned protocols.
• Monitor trial lifecycle activities for regulatory risk; escalate issues and propose mitigation strategies.
• Prepare 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.
• Coordinate safety reporting (SAEs, SUSARs, MedWatch) and ensure timely submissions to IRB/FDA/sponsors per protocol and regulation.
• Maintain accurate regulatory files and trial master files (TMF/eTMF), study binders, and tracking logs; uphold version control and audit trail integrity and ensure inspection readiness.
• Utilize electronic systems (e.g., CTMS, eTMF, IRB portals) to manage submissions, approvals, and study milestones.
• Assist in development and refine SOPs, work instructions, templates, and checklists to standardize high quality regulatory practices.
• Support investigators in protocol and consent development.
• Maintain and expand 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.
• Ensure adherence to FDA regulations, ICH‑GCP, HIPAA, OHRP, CMS/CLIA, state laws, and institutional SOPs.
• Partner with Quality/Compliance to prepare for audits/inspections (FDA, IRB, sponsor, internal); draft CAPAs and drive timely remediation.
• Work closely with the study team, research staff, and investigators, sponsor and sponsor representatives.
• Participates in feasibility, implementation, and site initiation meetings, teleconferences, monitor visits, research audits and other onsite meetings as required.
• Mentor junior regulatory staff; provide training on oncology/hematology regulatory topics and best practices.
• Contribute to continuous improvement initiatives (e.g. cycle‑time reduction, right‑first‑time metrics, automation, dashboards).
• Practice a high level of integrity and honesty in maintaining confidentiality.
• Perform other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Department Specific Criteria

• Must have excellent written and verbal communication skills; ability to translate complex regulatory requirements for diverse stakeholders.
• Excellent organization skills: Proven ability to manage multiple deadlines, competing priorities, and complex document workflows with high accuracy. Knowledge of medical/scientific terminology
• Experience with CTMS, eTMF, and IRB electronic systems
• Strong MS Office/365 skills (Word, Excel, PowerPoint, SharePoint, Teams)
• High sense of professional behavior and conduct and an ability to communicate with various levels of faculty and staff within Baylor College of Medicine and outside organizations 

Preferred Qualifications

• Masters or PhD in related discipline
• Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)
• Prior work in pediatric clinical research and/or hematology/oncology