Clinical Research Regulatory Specialist

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report’s 2024-2025 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

The primary purpose of this role is to direct, plan and coordinate protocol submissions and regulatory processes. In addition, the Clinical Research Regulatory Specialist is responsible for regulatory affairs, research compliance and research reporting within the Department of Surgical Oncology including development, quality assurance, and training.

The ideal candidate with have experience supporting large departments with technical proficiency with REDCAP, WCG IRB and Epic.

Protocol Submission and Regulatory Processes

• Manage and coordinate submission of all new protocols to IRB. Responsible for reviewing new protocol submission documents for completion and drafting materials as needed to enable protocol submission. Creates regulatory binder. To include oversight for items submitted by research team members within the department as appropriate and ensures timely resolution of all needs.
• Assists with activation of the study. Ensures all revisions are submitted and approved by the IRB within per Industry Sponsor or Cooperative Group time frame.
• Tracks the status of all new protocol submissions and revisions to ensure process remains on target for timelines. Intervenes, as needed, to assist with obtaining IRB approval on all types of protocols.
• Creates tracking reports for status review of all new protocol submissions. This includes all types of protocols: clinical, psychosocial, lab and data reviews.
• Create and submit monthly metrics to include all submissions, amendments, continuing reviews, and MTAs.
• Maintain, support, and provides education for compliance activities and database/systems (Prometheus, ePRTCL, eREG, OneIRB).
• Assist the Associate Director with data collection, drafting and submission of Material Transfer Agreements (MTA).
• Reviews protocol submissions for feasibility and works directly with the faculty for completion.
• Audit/Monitoring: Maintain regulatory study documents continuously in preparation for audits/monitoring. Manage access of external monitors in the myHR system. Create NTFs and assist monitors when on-site with copies of documents, visitor log completion, access to files, etc.

Development and Infrastructure

• Manages and monitors all department regulatory information housed within various institutional systems. Ensures all protocol, and amendment trainings, signatures are collected as required to meet compliance. Ensures all information is present and updated in the system and closed out as needed.
• Creates and maintains department regulatory SOPs. Update all SOPs and disseminates material to department for process education. Keeps all departmental regulatory policies in-line with institutional and federal regulation compliance requirements. Create and maintain a CV/medical license (ML)/training database to keep track of outstanding required regulatory items, CVs and MLs for all personnel working/collaborating on each study.

Reporting & Collaboration

• Meets with the Research Core Team weekly and/or as needed to discuss and review clinical research issues, including the status of proposed and ongoing clinical research studies.
• Attends monthly clinical research departmental and institutional meetings and conferences/seminars as relevant. Presents and provides key information and updates to the team and faculty.
• Communicates with research leadership to provide updates of department research, issue resolution, staffing information to facilitate compliance needs. Provides reports of research project information (activation, closing, termination) and discusses and needs or changes from IRB or institution that will affect departmental processes. Responsible for preparation of audits and monitoring as requested or notified.
• Participate and serve on the Department Auditing Team by completing all regulatory components of internal audits conducted by the committee. Provides coverage support to Administrative Director for leading Audit Committee.

Training

• Provides training and support for staff and other members of the clinical research teams.
• Educates and trains Faculty, Fellows, and research teams regarding Continuing Review, Informed Consent, and Protocol submissions for IRB approval. Works with new fellows and staff during onboarding to educate regarding the internal process for submission. Assist members of the team as needed to help facilitate the process and troubleshoot. In addition, ensures all projects by fellows are closed out appropriately when their appointments end.
• On/Off-boarding: participate in on-boarding of all new staff and fellows to discuss regulatory requirements/processes and GCP; Populate off-boarding checklist and work with departing staff to address missing/outdated training, CVs, DOAs, remove system/protocol access.

Other duties as assigned.