University of Utah Regulatory Coordinator in Salt Lake City, Utah

Details

Open Date 04/25/2017

Requisition Number PRN14090B

Job Title Regulatory Coordinator

Working Title Regulatory Coordinator

Job Grade E

FLSA Code Administrative

Patient Care Job Code? No

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Full time Monday-Friday 8-5pm. Some on call may be required.

VP Area Health Sciences

Department 00256 - Surgery Administration

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 39300 to 72700

Close Date

NOTE: May close at anytime.

Open Until Filled

NOTE: May close at anytime. Yes

Job Summary

Develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements working under the direct supervision of the Research Manager and the Department of Surgery Clinical Research Office.

Responsibilities

1.Supports all aspects of regulatory compliance.

2.Prepares regulatory documents, including consent forms for submission to research review committees.

3.Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.

4.Tracks study approvals and expirations to ensure uninterrupted project approval.

5.Tracks sponsor and investigator initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board (IRB), uTRAC,CMS,FDAetc.

6.Submits study renewal applications and study progress reports to theIRB.

7.Coordinates with study sponsor, investigator andIRBto complete study closure activities.

8.Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission.

9.Recommends and implements regulatory process improvements.

10.Maintains current knowledge of federal and institutional guidelines and requirements governing research.

11.Maintains regulatory databases.

12.Generates ad hoc reports as requested.

13.Assists with data collection, reporting, and entry intoEDCdatabases.

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.

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 not responsible for providing patient care.

Preferences

Type Benefited Staff

Special Instructions Summary

Additional Information

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: employment@utah.edu 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: oeo@umail.utah.edu .

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.