University of Oklahoma
*Senior Oncology Regulatory Specialist- CTO
University of Oklahoma, Oklahoma City, Oklahoma, United States, 73116
Job Title
Senior Oncology Regulatory Specialist- CTO (252014) Organization : OU Stephenson Cancer Center Job Details
Location : Onsite (Stephenson Cancer Center) Schedule : Full-time, Monday-Friday 8am-5pm Salary Range : Targeted annual salary ranges from $38,700 to $50,300, based on experience. Benefits Provided : Yes Required Attachments : Resume Overview
OU Health Stephenson Cancer Center is Oklahomas only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 73 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options. At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you! The
Senior Oncology Regulatory Specialist - CTO
position, under minimal supervision, performs tasks with judgement and determines the proper course of action while following established standards. Responsible for coordinating regulatory and Institutional Review Board (IRB) activities of clinical research, revisions to the Informed Consent Form, and grant support. This position adheres to the University Compliance program, Code of Ethics, and Business Standards. Learn more about the Stephenson Cancer Centers Clinical Trials Office here. Duties / Responsibilities
Format, collect, and timely preparation of documents for regulatory submissions in accordance with FDA and trial sponsor specifications. Track collection progress through regulatory workflows. Maintain a working knowledge of regulations, submission requirements and processes for multiple regulatory systems. Help create and update regulatory workflows in collaboration with Clinical Trials Manager - Regulatory Affairs to adapt and adjust to changing regulations and processes. Train regulatory specialists on current or new processes and workflows. Provide guidance and instructions to regulatory specialists and research personnel on regulatory affairs requirements and procedures. Communicate important regulatory and study related information to the Research Team, Sponsors or regulatory authorities throughout the regulatory process. Independently manage and maintain a portfolio of studies with minimal supervision. Ensure studies meet regulatory, GCP and institutional guidelines and processes. Track milestones and ensure deadlines are met on multiple projects for a team of regulatory specialists. Perform various duties as needed to successfully fulfill the functions of the position. Qualifications / Job Requirements
Required Education : Associates Degree 24 months of regulatory/compliance experience Equivalency/Substitution : Will accept 24 months of equivalent experience in lieu of the Associate's degree for a total of 48 months experience. Skills Advanced knowledge of compliance and regulatory concepts, guidelines, and principles. Advanced proficiency with Microsoft Office Suite and other software systems. Must be detail oriented and have excellent organization skills. Ability to communicate verbally and in writing. Working Conditions Physical : Sit for prolonged periods. Communicate effectively and listen. Engage in repetitive motion. Use of computer and telephone. Stand, stoop, bend, and reach. Environmental : Standard office environment. Company Values & Equal Opportunity
Why You Belong at the University of Oklahoma : The University of Oklahoma values our community's unique talents, perspectives, and experiences. At OU, we aspire to harness our innovation, creativity, and collaboration for the advancement of people everywhere. You Belong Here! Equal Employment Opportunity Statement : The University, in compliance with all applicable federal and state laws and regulations, does not discriminate on the basis of race, color, national origin, sex, sexual orientation, marital status, genetic information, gender identity/expression (consistent with applicable law), age (40 or older), religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures. This includes but is not limited to admissions, employment, housing, financial aid, and educational services. Hiring contingent upon a Background Check: Yes Special Indications: None Job Posting
Job Posting : Sep 5, 2025 Job Description Help Required Attachments
- Documents required for this position are listed under the "Required Attachments" section of this job listing. You will be required to upload and attach these documents in the application process. Important : ALL required documents must be attached to your job application or your documents will not be visible to the hiring department! #J-18808-Ljbffr
Senior Oncology Regulatory Specialist- CTO (252014) Organization : OU Stephenson Cancer Center Job Details
Location : Onsite (Stephenson Cancer Center) Schedule : Full-time, Monday-Friday 8am-5pm Salary Range : Targeted annual salary ranges from $38,700 to $50,300, based on experience. Benefits Provided : Yes Required Attachments : Resume Overview
OU Health Stephenson Cancer Center is Oklahomas only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 73 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options. At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you! The
Senior Oncology Regulatory Specialist - CTO
position, under minimal supervision, performs tasks with judgement and determines the proper course of action while following established standards. Responsible for coordinating regulatory and Institutional Review Board (IRB) activities of clinical research, revisions to the Informed Consent Form, and grant support. This position adheres to the University Compliance program, Code of Ethics, and Business Standards. Learn more about the Stephenson Cancer Centers Clinical Trials Office here. Duties / Responsibilities
Format, collect, and timely preparation of documents for regulatory submissions in accordance with FDA and trial sponsor specifications. Track collection progress through regulatory workflows. Maintain a working knowledge of regulations, submission requirements and processes for multiple regulatory systems. Help create and update regulatory workflows in collaboration with Clinical Trials Manager - Regulatory Affairs to adapt and adjust to changing regulations and processes. Train regulatory specialists on current or new processes and workflows. Provide guidance and instructions to regulatory specialists and research personnel on regulatory affairs requirements and procedures. Communicate important regulatory and study related information to the Research Team, Sponsors or regulatory authorities throughout the regulatory process. Independently manage and maintain a portfolio of studies with minimal supervision. Ensure studies meet regulatory, GCP and institutional guidelines and processes. Track milestones and ensure deadlines are met on multiple projects for a team of regulatory specialists. Perform various duties as needed to successfully fulfill the functions of the position. Qualifications / Job Requirements
Required Education : Associates Degree 24 months of regulatory/compliance experience Equivalency/Substitution : Will accept 24 months of equivalent experience in lieu of the Associate's degree for a total of 48 months experience. Skills Advanced knowledge of compliance and regulatory concepts, guidelines, and principles. Advanced proficiency with Microsoft Office Suite and other software systems. Must be detail oriented and have excellent organization skills. Ability to communicate verbally and in writing. Working Conditions Physical : Sit for prolonged periods. Communicate effectively and listen. Engage in repetitive motion. Use of computer and telephone. Stand, stoop, bend, and reach. Environmental : Standard office environment. Company Values & Equal Opportunity
Why You Belong at the University of Oklahoma : The University of Oklahoma values our community's unique talents, perspectives, and experiences. At OU, we aspire to harness our innovation, creativity, and collaboration for the advancement of people everywhere. You Belong Here! Equal Employment Opportunity Statement : The University, in compliance with all applicable federal and state laws and regulations, does not discriminate on the basis of race, color, national origin, sex, sexual orientation, marital status, genetic information, gender identity/expression (consistent with applicable law), age (40 or older), religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures. This includes but is not limited to admissions, employment, housing, financial aid, and educational services. Hiring contingent upon a Background Check: Yes Special Indications: None Job Posting
Job Posting : Sep 5, 2025 Job Description Help Required Attachments
- Documents required for this position are listed under the "Required Attachments" section of this job listing. You will be required to upload and attach these documents in the application process. Important : ALL required documents must be attached to your job application or your documents will not be visible to the hiring department! #J-18808-Ljbffr