Lead Oncology Research Regulatory Specialists CTO
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Job Location:
Oklahoma City, OK - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 Lead Oncology Research Regulatory Specialist - CTO position serves as lead to other specialists. Performs coordination of regulatory and Institutional Review Board (IRB) activities of clinical research including 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:
- Assumes day-to-day responsibility for coordinating regulatory and IRB activities of clinical research.
- Provides guidance and subject matter expertise to other members of the research team for regulatory and compliance aspects of conducting clinical research.
- Maintains documentation in compliance with federal and local regulations
- Formats collects and prepares documents for regulatory submissions in accordance with FDA and trial sponsor specifications. Tracks collection progress through regulatoryworkflows.
- Helps create and update regulatory workflows in collaboration with Clinical Trials Manager - Regulatory Affairs to adapt and adjust to changing regulations and processes.
- Trains regulatory specialists on current or new processes and workflows. May provide supervision of staff.
- Communicates 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.
- Tracks milestones and ensure deadlines are met on multiple projects for a team of regulatory specialist.
- Performs various duties as needed to successfully fulfill the functions of the position.
Required Education: Associates Degree AND:
- 36 months of regulatory/compliance experience.
Equivalence/Substitution: Experience or a combination of education & related experience can be considered in lieu of degree. A one-to-one ratio is used to determine the number of years of experience required in place of a degree.
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.
- Standard office environment.
Why You Belong at the University of Oklahoma:The University of Oklahoma values our communitys 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.
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.
Required Experience:
Chief
Key Skills
- Hospital Experience
- Acute Care
- Basic Life Support
- ICU Experience
- Infusion Experience
- Triage
- TFS
- Conflict Management
- Nursing
- Critical Care Experience
- Epic
- Medication Administration
