PS Regulatory Coordinator
University of Utah
Salt Lake City, UT
Full-time
Management
Posted on April 6, 2024
Announcement
Details
Open Date
02/01/2024
Requisition Number
PRN37601B
Job Title
PS Regulatory Coordinator
Working Title
Regulatory Coordinator
Job Grade
E
FLSA Code
Administrative
Patient Sensitive Job Code?
Yes
Standard Hours per Week
40
Full Time or Part Time?
Full Time
Shift
Day
Work Schedule Summary
Monday – Friday 8:00 am – 4:30 pm
VP Area
U of U Health - Academics
Department
00848 - Pediatric Administration
Location
Campus
City
Salt Lake City, UT
Type of Recruitment
External Posting
Pay Rate Range
$39,300 - $68,349
Close Date
Open Until Filled
Yes
Job Summary
Job Summary
The division of Pediatric Genetics has an immediate opening for a Regulatory Coordinator.
This position develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements.
Positions are designed to provide growth and professional development opportunities, including promotions within a defined career ladder.
The University of Utah offers a comprehensive benefits package including:
Responsibilities
E ssential Functions
This position utilizes federal, ICH/ GCP and 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.
This 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.
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
Type
Benefited Staff
Special Instructions Summary
Additional Information
The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS' post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.
This position may require the successful completion of a criminal background check and/or drug screen.
The University of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.
All qualified individuals are strongly encouraged to apply. Veterans' preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.
The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran's status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.
To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action (OEO/AA). More information, including the Director/Title IX Coordinator's office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
Required Documents
Details
Open Date
02/01/2024
Requisition Number
PRN37601B
Job Title
PS Regulatory Coordinator
Working Title
Regulatory Coordinator
Job Grade
E
FLSA Code
Administrative
Patient Sensitive Job Code?
Yes
Standard Hours per Week
40
Full Time or Part Time?
Full Time
Shift
Day
Work Schedule Summary
Monday – Friday 8:00 am – 4:30 pm
VP Area
U of U Health - Academics
Department
00848 - Pediatric Administration
Location
Campus
City
Salt Lake City, UT
Type of Recruitment
External Posting
Pay Rate Range
$39,300 - $68,349
Close Date
Open Until Filled
Yes
Job Summary
Job Summary
The division of Pediatric Genetics has an immediate opening for a Regulatory Coordinator.
This position develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements.
Positions are designed to provide growth and professional development opportunities, including promotions within a defined career ladder.
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
Responsibilities
E ssential Functions
- Supports all aspects of regulatory compliance.
- 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 Institutional Review Board (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.
- Recommends and implements regulatory process improvements.
- Maintains current knowledge of federal and institutional guidelines and requirements governing research.
- Maintains regulatory database.
- Generates ad hoc reports as requested.
This position utilizes federal, ICH/ GCP and 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.
This 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.
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
Type
Benefited Staff
Special Instructions Summary
Additional Information
The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS' post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.
This position may require the successful completion of a criminal background check and/or drug screen.
The University of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.
All qualified individuals are strongly encouraged to apply. Veterans' preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.
The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran's status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.
To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action (OEO/AA). More information, including the Director/Title IX Coordinator's office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
- * Do you have a Bachelor's degree in a research or related area or equivalency? (2 years related work experience may be substituted for 1 year of education).
- No
- Yes
- * How many years of clinical trials/research experience do you have?
- Less than 2 years
- 2 years or more, but less than 4 years
- 4 years or more, but less than 6 years
- 6 years or more, but less than 8 years
- 8 years or more
Required Documents
- Resume
- Cover Letter
- Addendum to the University of Utah - Veteran Only - Call 801.581.2169 after submission
- Appropriate discharge document (such as a DD-214 – Member Copy 4) – Veteran Only – Call 801.581.2169
