PS Regulatory Coordinator

PS Regulatory Coordinator

Job Summary

Within the Obstetrics and Gynecology Research Network (OGRN), the Regulatory Coordinator is responsible to oversee and manage all activities associated with all research conducted within the OBGYN Department to ensure protection of human subjects. These duties may include (but are not limited to): submission of new study applications to the University of Utah IRB system (ERICA); single IRB reliance planning, review and submission; UPDB/RGE applications; data and material transfer agreement management; Investigational New Drug (FDA) application submission and management; industry sponsored study start-up and close out.

Responsibilities
Regulatory/Compliance/General Responsibilities

• Ensures all research protocols and needed documents are submitted for IRB initial approval, amendment or continuing review in a timely manner. Confirm with Associate Director of Research to determine timelines for new study submission (NIH funded, industry sponsor funded, investigator initiated, etc.).
• Track and save all IRB approved applications and documents as approved by the IRB.
• Interprets and provides comprehensive guidance to principal investigators, research and support staff on complex human subjects' research regulations.
• Assists in the identification of potential regulatory issues with human subjects research protocols and assists in developing ethical and appropriate ways to resolve these issues.
• Provides detailed support and procedural guidance to the study team to ensure the conduct of high-quality human subject research.
• Meets with new research team members to review required regulatory trainings for onboarding process.
• Responds to and prepares for any external compliance audits.
• Assists with study feasibility surveys as necessary.
• Provides all required regulatory documents to industry and federally funded sponsors prior to study initiation.
• Prepares for and completes documents for new study Site-Initiation-Visits.
• Prepares and reviews all required documents for complete regulatory binders (training logs, delegation of authority, etc.).
• Stays up-to-date on University of Utah research-related policies and standard operating procedures and works with OGRN Research Associate to create and maintain Process and Procedure Documents for the department, as needed.
• Assists PI's with FDA Investigational New Drug (IND) initial submissions. Manages safety reporting, annual reporting, communications and close-out documents.
• Maintain and update (as appropriate) current IRB allowable recruitment and consent process language for all research studies within the department.
• UTRAC application initiation and exemption requests (when applicable).
• Attends all requires meetings.
• Assists with OGRN orientation for incoming Residents, Fellows and new Faculty.
• Ensures all research team members are current with required compliance trainings (CITI/GCP/COI, etc.)

Problem Solving Incumbents face the challenge of staying abreast of continually changing human research regulations in order to make changes to internal policies and procedures to ensure compliance with the new regulations, as well as communicating the changes in an effective and timely manner.

Team Culture

• Supports an inclusive, transparent and supportive work environment
• Reliable, displays a positive attitude, does not engage in gossip, supports the team and is flexible
• Communicates problems, issues and frustrations to supervisor and/or OB/WCSL Leadership

University of Utah Health Benefits Package University of Utah Health is proud to offer a generous benefits package! Our healthcare plans include medical and dental coverage, prescriptions, basic vision coverage, and behavior health benefits. Employees are eligible for a discount of up to $40 per month on their premiums for participating in our Well-U Wellness Program. Our retirement plan includes automatic enrollment into our University-funded 401(a) plan with a contribution rate of 14.2%! Additional benefits include half-off tuition for employees, their spouses, and their dependent children, University-provided Part I life insurance, and discounts through many retail vendors who have teamed up with the University. Visit our Benefits website for more information at www.hr.utah.edu/benefits.
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.

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: PRN40316B
Full Time or Part Time? Part Time
Work Schedule Summary: Monday - Friday. Flexible within standard business hours.
Department: 00931 - Ob/Gyn Research Network
Location: Campus
Pay Rate Range: 39300 to 68349
Close Date: 1/10/2025
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/173932


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