PS Regulatory Coordinator
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Details
Open Date 06/23/2022
Requisition Number PRN31133B
Job Title PS Regulatory Coordinator
Working Title PS 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
VP Area U of U Health - Academics
Department 00234 - Geriatrics
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 39300 to 64349
Close Date
Open Until Filled Yes
Job Summary
Develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements.
Responsibilities
Disclaimer
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Essential Functions
- Supports all aspects of regulatory compliance.
- Coordinates and performs responsibilities related to research participants including determining subject population availability, screening and recruiting subjects, scheduling visits, obtaining informed consent, and answering subject inquiries.
- Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.
- Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines.
- Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.
- Determines length of visits and coordinates related facility and equipment availability.
- Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
- 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.
- May perform functions required of the Clinical Research Assistant as necessary.
- Coordinates and maintains accurate databases.
Problem Solving
This 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.
Comments
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.
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 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 of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.
Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are 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:
Director/ Title IX Coordinator
Office of Equal Opportunity and Affirmative Action ( OEO /AA)
135 Park Building
Salt Lake City, UT 84112
801-581-8365
Online reports may be submitted at oeo.utah.edu
For more information: https://www.utah.edu/nondiscrimination/
To inquire about this posting, email:[email protected] (%[email protected]) or call 801-581-2300.
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.