Regulatory Coordinator - Cancer Center
About The Position
The Regulatory Coordinator is responsible for performing study-specific regulatory and safety reporting across multiple studies. This will be accomplished by: assuring the research is compliant with applicable federal, state or international requirements, while adhering to policies of The University of Kansas Medical Center. This position will be the assigned contact for study-start up activities including IRB/Ancillary committee submissions, and maintenances of regulatory records throughout the life of an assigned protocol. The University of Kansas Cancer Center is the region's only National Cancer Institute-designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
Requirements
- Four (4) years of work experience in healthcare or research setting. Education may be substituted for experience on a year for year basis.
- Work experience in an environment requiring an understanding of regulations governing clinical research (CFR, GCP, HIPAA) and statutes and guidelines relevant to regulatory affairs in clinical research.
- Experience with medical terminology and concepts.
- Experience with Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
Nice To Haves
- Bachelor’s degree in relevant field like health sciences, biology, nursing, or a related field.
- Initiative
- Organization
- Detail-Oriented
- Interpersonal
- Multitasking
- Communication
- Analytical
- Problem-solving
- Time management
Responsibilities
- Prepare and submit all regulatory documents including to the Institutional Review Board, collaborate with team members to ensure regulatory documents are complete and accurate.
- Process, route, and track regulatory documents for study start-up.
- Maintain trial master file and/or regulatory binder.
- Maintain study files for team credentials (GCP Training, CV, Medical License).
- Provide assistance to study monitors during routine monitor visits or audits.
- Update protocol-specific systems with complete and accurate protocol and study information.
- Update regulatory documents as assigned: Adding/removing study team members from regulatory documents, Printing, sorting, and filing documents, Updating templates.
- Work closely with investigators, study personnel, and sponsors on relevant regulatory and/or safety concerns.
- Ensure activities are conducted in a professional and ethical manner, and in accordance with KUMC Policies and applicable local, state and federal laws and regulations.
- Ensure coordination of area work with other areas of KUMC to ensure integration and support of KUMC goals and objectives.
- May participate in relevant committees, task force, or other similar activities.
- Maintain confidentiality of medical center, employee, and patient information. Handle sensitive data with discretion and in accordance with KUMC policies and legal requirements.
Benefits
- health, dental, and vision insurance
- health expense accounts with generous employer contributions
- Employer-paid life insurance
- long-term disability insurance
- various additional voluntary insurance plans
- Paid time off, including vacation and sick
- ten paid holidays
- One paid discretionary day after six months of employment
- paid time off for bereavement, jury duty, military service, and parental leave after 12 months of employment
- A retirement program with a generous employer contribution
- additional voluntary retirement programs (457 or 403b)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
