Summary

The Senior Regulatory Affairs Associate 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.

A Senior Regulatory Affairs Associate will be assigned studies with complex regulatory aspects. This may include studies with IND filings and requires significant prior regulatory experience including sponsor-investigator held INDs. The role is instrumental in ensuring ongoing study compliance (from a regulatory perspective). This role is highly independent with little direction from the supervisor but lots of experience to drive their work.

This position is eligible for future potential hybrid work schedule.

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

Job Duties

• Independently completes and coordinates regulatory correspondence across internal stakeholders and external institutions.
• Provides protocol feedback, 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.
• Assists in training junior staff on the team and serves as a resource to staff for general regulatory guidance.
• Provides coverage for team members as needed.
• Works with the Director to provide input on SOP revisions and adopting required regulatory changes.
• Maintain 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.
• Works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
• Facilitates communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
• Assures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects.
• Maintains 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.
• 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

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

Department Specific Criteria

• Four years of experience in regulatory affairs and/or clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations.
• 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, sponsor-investigator held INDs and other human subjects research protection requirements.

Preferred Qualifications

• Certification in Clinical Research, SOCRA or other preferred.
• Ability to serve as a resource to clinical investigators and staff.
• Ability to manage shifting priorities in short time frames.
• Should have 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.