Summary

The Regulatory Affairs Specialist 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 an understanding of clinical research and applicable regulations.

The Regulatory Affairs Specialist will be assigned large consortium protocols using a central IRB where there is little need to revise patient consent forms, align subject injury language with contracts, review protocol for discrepancies/suggestions, processing continuing review submissions. This role will process protocols. When there is variation from this process, they are needing direction.

Job Duties

• Follows SOPs and 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.
• Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals and that protocol amendments are submitted appropriately and that annual renewals are obtained.
• Works closely with the study team at the guidance of the Director, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
• Enables communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
• Follows SOPs and ensures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects.
• Maintains regulatory database as applicable and maintains electronic and paper study files in accordance with local SOPs, sponsor and general industry standards ensuring documentation is complete, up to date, and audit ready.
• Keeps the study team and supervisor informed of protocol related issues.
• Practices a high level of integrity and honesty in maintaining confidentiality.
• Works proactively and collaboratively with other team members to streamline work and achieve mutual goals.
• Attends all required meetings, contributes pertinent protocol information and uses information presented to develop an understanding of the hematology/oncology landscape, in order to more accurately assist in the preparation of submissions.
• Plans and pursues activities to promote self development related to hematology/oncology and regulatory issues.

Minimum Qualifications

• High School diploma or GED.
• Four years of relevant experience.

Preferred Qualifications

• Bachelor’s degree can replace experience.
• Experience in regulatory affairs for clinical research preferred.
• Certification in Clinical Research, SOCRA or other preferred.
• Knowledge and understanding of clinical research compliance, including OHRP, FDA and other federal regulations and requirements regarding human subjects.
• Research, including but not limited to GCPs and related ICH guidelines, informed consent, adverse event reporting and monitoring, and other human subjects research protection requirements.
• Ability to serve as a resource to clinical investigators and staff.
• Excellent oral and written communication skills
• Knowledge of medical/scientific terminology.
• Excellent organization skills; ability to multi-task.
• Strong computer skills, including Microsoft Office Suite.
• 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 organization.
• Knowledge of clinical research and/or regulatory processes and the applicable federal regulations and ICH GCP guidelines.
• Ability to manage shifting priorities in short time frames.