University of Oklahoma
*Sr. Oncology Research Regulatory Specialist - CTO
University of Oklahoma, Oklahoma City, Oklahoma, United States, 73116
Sr. Oncology Research Regulatory Specialist - CTO
19 hours ago Be among the first 25 applicants
OU Health Stephenson Cancer Center is Oklahoma’s 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.
Duties
Format, collect, and prepare documents for regulatory submissions in accordance with FDA and trial sponsor specifications. Track progress through regulatory workflows.
Maintain a working knowledge of regulations, submission requirements, and processes for multiple regulatory systems.
Create and update regulatory workflows in collaboration with the Clinical Trials Manager – Regulatory Affairs to adapt 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 palette of studies with minimal supervision, ensuring studies continue to meet regulatory, GCP, and institutional guidelines.
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.
Job Requirements Required Education:
Bachelor’s Degree, and
3 years of experience in regulatory affairs, compliance, clinical data informatics, or a related field in healthcare, research, pharmaceuticals, biotechnology, or a similarly regulated industry.
Equivalence/Substitution:
Will accept 24 months of equivalent experience in lieu of the Associate’s degree for a total of 48 months experience.
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.
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, 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 Conditions Hiring contingent upon a background check.
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OU Health Stephenson Cancer Center is Oklahoma’s 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.
Duties
Format, collect, and prepare documents for regulatory submissions in accordance with FDA and trial sponsor specifications. Track progress through regulatory workflows.
Maintain a working knowledge of regulations, submission requirements, and processes for multiple regulatory systems.
Create and update regulatory workflows in collaboration with the Clinical Trials Manager – Regulatory Affairs to adapt 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 palette of studies with minimal supervision, ensuring studies continue to meet regulatory, GCP, and institutional guidelines.
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.
Job Requirements Required Education:
Bachelor’s Degree, and
3 years of experience in regulatory affairs, compliance, clinical data informatics, or a related field in healthcare, research, pharmaceuticals, biotechnology, or a similarly regulated industry.
Equivalence/Substitution:
Will accept 24 months of equivalent experience in lieu of the Associate’s degree for a total of 48 months experience.
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.
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, 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 Conditions Hiring contingent upon a background check.
#J-18808-Ljbffr