Regulatory Affairs Specialist

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.

• Work on the regulatory maintenance of assigned clinical research protocols.
• Revise patient consent forms, align subject injury language with contracts, review protocol for discrepancies/suggestions, submit and process continuing review submissions as well as assist with other reporting requirements for assigned projects. 
• Follow SOPs, 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.
• Maintain and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.
• Act as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained.
• At the guidance of the Director, work closely with the study team, 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.
• Following SOPs, ensures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects
• Maintain regulatory database as applicable. 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
• Keep the study team and supervisor informed of protocol related issues.
• Complete other tasks as assigned.
• Practice a high level of integrity and honesty in maintaining confidentiality.
• Worksproactively and collaboratively with other team members to streamline work and achieve mutual goals.
• Attend 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.
• Plan and pursues activities to promote self development related to hematology/oncology and regulatory issues.
• Assist in maintenance/collection of central files and coordinating/tracking system access for research personnel.

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

• Bachelor’s degree in a related field. 
• Four or more years of experience in regulatory affairs and/or clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations. Experience in regulatory affairs for clinical research preferred. Bachelor’s degree can replace experience.
• 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.
• Ability to manage shifting priorities in short time frames.
• 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 organizations.
• Knowledge of clinical research and/or regulatory processes and the applicable federal regulations and ICH GCP guidelines.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

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