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1 week ago
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2 weeks ago
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Senior Oncology Regulatory Specialist - Oklahoma City, United States - University of Oklahoma
Description
Job Description - *Senior Oncology Regulatory Specialist*Senior Oncology Regulatory Specialist
Job Number
:
241388
Organization
Job Location
Schedule
Schedule
:
Full-time
Work Schedule
:
Monday-Friday 8am-5pm
Work Type
:
Onsite
Salary Range
:
Targeted annual salary ranges from $38,700 to $50,300, based on experience.
Benefits Provided
:
Yes
Required Attachments
:
Resume
Job Description
Job Description
OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 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 TheSenior Oncology Regulatory Specialist
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 Center's Clinical Trials Office
here.
Duties:
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.
Training regulatory specialists on current or new processes and workflows. Provide guidance and instructions to regulatory specialists, 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 and processes.
Track milestones and ensure deadlines are met on multiple projects for a team of regulatory specialist.
Perform various duties as needed to successfully fulfill the functions of the position.
Job Requirements
Job Requirements
Required Education:
Associate's Degree
AND:
24 months of regulatory/compliance experience
Equivalence/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 level of 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 listens. Engage in repetitive motion. Use of computer and telephone. Stand, stoop, bend, and reach.
Environmental:
Standard office environment.
Why You Belong at the University of Oklahoma:
The University of Oklahoma fosters an inclusive culture of respect and civility, belonging, and access, which are essential to our collective pursuit of excellence and our determination to change lives.
The unique talents, perspectives, and experiences of our community enrich the learning, and working environment at OU, inspiring us to harness our innovation, creativity, and collaboration for the advancement of people everywhere.
Equal Employment Opportunity Statement:
The University of Oklahoma, in compliance with all applicable federal and state laws and regulations, does not discriminate based on race, color, national origin, sex, sexual orientation, genetic information, gender identity, gender expression, age, 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, financial aid, housing, services in educational programs or activities, and health care services that the University operates or provides.
Hiring contingent upon a Background Check?:
Yes
Special Indications
:
None
Job Posting
Job Posting
:
May 23, 2024
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
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Senior Oncology Regulatory Specialist professionals in Oklahoma City
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Antoinette Williams
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