University of Utah Regulatory Coordinator in Salt Lake City, Utah
Open Date 05/30/2017
Requisition Number PRN14322B
Job Title Regulatory Coordinator
Working Title Regulatory Coordinator
Job Grade E
FLSA Code Administrative
Patient Care Job Code? No
Standard Hours per Week 40 hours
Full Time or Part Time? Full Time
Work Schedule Summary
VP Area Health Sciences
Department 01497 - HCI Popul Research Compliance
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 39300 to 72700
NOTE: May close at anytime.
Open Until Filled
NOTE: May close at anytime. Yes
Develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements.
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 theIRB.
Coordinates with study sponsor, investigator andIRBto 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, 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.
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.
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.
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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 not responsible for providing patient care.
Type Benefited Staff
Special Instructions Summary
The University of Utah is an Affirmative Action/Equal Opportunity employer and is committed to diversity in its workforce. In compliance with applicable federal and state laws, University of Utah policy of equal employment opportunity prohibits discrimination on the basis of race or ethnicity, religion, color, national origin, sex, age, sexual orientation, gender identity/expression, veteran’s status, status as a qualified person with a disability, or genetic information. Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities, and protected veterans are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.
To inquire about this posting, email: email@example.com or call 801-581-2300. Reasonable accommodations in the application process will be provided to qualified individuals with disabilities. To request an accommodation or for further information about University AA/EO policies, please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/ TDD ), email: firstname.lastname@example.org .
The University is a participating employer with Utah Retirement Systems (“URS”). To be eligible for retirement contributions, you must be hired into a benefit-eligible position. Certain new hires are automatically assigned to the URS retirement plan and other employees with prior URS service, may elect to enroll in the URS within 30 days of hire. Regardless of whether they are hired into a benefit-eligible position or not, individuals who previously retired and are receiving monthly retirement benefits from URS must notify the Benefits Department upon hire. Please contact Utah Retirement Systems at (801)366-7770 or (800)695-4877 or the University’s Benefits Department at (801)581-7447 for information.
This position may require the successful completion of a criminal background check and/or drug screen.