Regulatory Affairs Specialist

Summary

The Regulatory Affairs Specialist works to support the investigators and clinical research operations associated with The Texas Children's Cancer and Hematology Centers (TXCH). This position supports all aspects of regulatory compliance for a specified portfolio of over 80 studies. 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 role covers a significant portion of our Phase 1 protocols as well as protocols from our most prolific consortia (PBTC and PNOC) which require specific tasks and expertise. 

A Specialist will be assigned low to mid regulatory complexity  projects including large consortium protocols using a central IRB where there are less editing needs. The Specialist will handle assigned protocols independently including but not limited to sponsor correspondence, monitoring, review board submissions (initial, amendments, renewals). This role will centrally process safety reports, consortium correspondence, broadcast reviews and distirbution, team mailbox tasks, protocol approvals. The Specialist will work with their assigned PIs to maintain compliance for their assigned protocols and will cover for their peers as needed. For more complex projects, they are needing direction.

Job Duties

• Follows 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.
• 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, that protocol amendments are submitted appropriately and that annual renewals are obtained.
• At the guidance of the Director, works 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.
• Follows SOPs, ensures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects
• Maintains regulatory database and systems as applicable (e.g. CTMS, OneDrive, Advarra eReg). 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.

Minimum Qualifications

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

Preferred 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 academic medical center or hospital with knowledge of clinical research practices and regulations.
• 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.
• Ability to manage shifting priorities in short time frames.

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

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