PS Regulatory Coordinator

PS Regulatory Coordinator

Job Summary

Job Summary
The Division of Pediatric Hematology-Oncology, BMT & Immunology in the University of Utah School of Medicine has an immediate opening for a Regulatory Coordinator. This is an exciting opportunity to be a part of the Research Enterprise team of the Division of Hematology/Oncology. This position supports a myriad of consortium and industry/governmental sponsored trials focused on pediatric cancer. Come be part of the team to help in the fight against childhood cancer!
 
The Regulatory Coordinator Develops and coordinates the submission of regulatory documents to ensure compliance with all governing requirements. Supports the Principal Investigator and study team ensuring compliance with all University, state and federal regulations that govern clinical research. Prepares applicable submission forms and submits updated documents to the IRB including but not limited to: Amendments, Addendums, Investigator's Brochures, Safety Information, Form FDA 1572s and informed consent documents. Maintains and accurately files all necessary logs within the regulatory binder(s). Maintains all regulatory files for each trial assigned by maintaining accurate filing and recording of regulatory information. Autonomy, creativity, and critical thinking skills are strongly encouraged and welcomed.
 
This position will report directly to the Clinical Research Manager of the Hematology/Oncology/BMT Research Enterprise.

The University of Utah offers a comprehensive benefits package including:

• Excellent health care coverage at affordable rates
• 14.2% retirement contributions that vest immediately
• Generous paid leave time 
• 11 paid Holidays per year
• 50% tuition reduction for employee, spouse, and dependent children
• Flex spending accounts
• Free transit on most UTA services
• Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
• Professional development opportunities

Additional benefits information is available at https://benefits.utah.edu/ 

Responsibilities
Essential Functions

• Supports all aspects of regulatory compliance. Prepares, facilitates, submits and maintains the process for accurate and timely submission of IRB applications for protocol revisions or amendments, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in informed consent, or dual enrollment to additional studies for IRB approved protocols as required by the federal regulations and internal policy.
• Facilitates and coordinates all aspects of IRB submissions. This includes evaluating protocol changes and incorporating those changes into the informed consent form in language understandable to the participant as required by the specific revisions made to the research protocol.
• Completes, audits, and maintains study records, materials, and databases to ensure compliance with study protocols, FDA, IRB, departmental, and university regulations.
• Prepares regulatory documents, including consent forms for submission to research review committees.
• Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
• Tracks study approvals and expirations to ensure uninterrupted project approval.
• Tracks sponsor and investigator-initiated amendment notifications and submits amended protocols, summaries, and consents to the IRB.
• Submits study renewal applications and study progress reports to the IRB.
• Coordinates with study sponsor, investigator, and IRB to complete study closure activities.
• Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission.
• Assists in aiding trial activation across disciplines as needed.
• Recommends and implements regulatory process improvements.
• Maintains current knowledge of federal and institutional guidelines and requirements governing research.
• Demonstrates initiative, enthusiasm, positive attitude, teamwork, and commitment to the research mission of the department by providing support as needed and where directed.

Problem SolvingThis position utilizes federal, institutional guidelines and requirements to inform and complete submission of regulatory documents. This position also negotiates with University research committees and sponsors to ensure full compliance and communication. CommentsThis position requires a sophisticated understanding of regulatory requirements. The ability to effectively communicate verbally and in writing is also needed with a high level of attention to detail and follow-through. Work Environment and Level of Frequency typically required:

• Nearly Continuously: Office environment.
• Physical Requirements and Level of Frequency that may be required
• Nearly Continuously: Sitting, hearing, listening, talking.
• Often: Repetitive hand motion (such as typing), walking.
• Seldom: Bending, reaching overhead.

The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient's status and provide care as described in the department's policies and procedures manual.

Minimum Qualifications
Bachelor's degree in a research or related area plus two years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required; demonstrated human relations and effective communication skills also required.

One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred.

This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Preferences


Special Instructions


Requisition Number: PRN40177B
Full Time or Part Time? Full Time
Work Schedule Summary: Full time, Monday - Friday, 8:00 am - 5:00 pm with occasional evenings and weekends required. Shared on-call responsibilities. Opportunities for a hybrid telework schedule may be available if supported by operational needs.  Employees may need to provide their own home office space, internet connection, telephone, and have the ability to work independently. 
Department: 00848 - Pediatric Administration
Location: Campus
Pay Rate Range: $39,300-$68,349
Close Date: 1/23/2025
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/173064


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