Job Information

University of Utah Regulatory Coordinator, Sr in Salt Lake City, Utah

Open Date 07/13/2021

Requisition Number PRN26906B

Job Title Regulatory Coordinator, Sr

Working Title

Job Grade F

FLSA Code Administrative

Patient Sensitive Job Code? No

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Monday thru Friday

VP Area U of U Health - Academics

Department 02148 - Clinical Research Service Ofc

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 47600 to 70000

Close Date

Open Until Filled Yes

Job Summary

The Clinical and Translational Science Institute ( CTSI ) is seeking a highly motivated individual to join our OnCore team in the Clinical Research Support Office ( CRSO ). This position will lead the implementation and rollout of the electronic regulatory management system within OnCore. The OnCore e-Regulatory Coordinator/trainer is responsible for implementation of the e-regulatory binder system as well as the development, planning, documentation, and delivery of training for OnCore e-regulatory initiatives. Experience with human subject research, regulatory compliance and working knowledge of ICH GCP and FDA regulations required. Clinical research experience is required and project management and training development skills is preferred. Primary resource for validating and maintaining 21 CFR compliance. Demonstrated effective communication skills also required.

Responsibilities

· In collaboration with the OnCore implementation team, lead the roll out of Advarra E-regulatory binder system across the University

· Orchestrate and drive the successful and timely completion of training, orientation, and continuing education programs for this system

· Develop an annual training and education plan, create and maintain training materials, execute classroom training for system end users

· Coordinate and track orientation of new/transfer employees to completion of OnCore e-regulatory research training

· Collaborate with OnCore end users, technical support, key stakeholders and organizational leadership, provide support to end users

· Coordinate the evaluation of upgrades on the test environment and provide feedback to Advarra product support regarding the new functionality

· Identify requirements and develop reports to meet organizational reporting needs

· Participate in data migration in collaboration with OnCore and research teams across campus

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 four years clinical trials/research experience or equivalency required; demonstrated human relations and effective communication skills also required.

Three years of regulatory experience, an understanding of medical terminology and technical writing experience required.

This position is not responsible for providing patient care.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

· Knowledge of 21 CRF compliance, validation processes and procedures

· 3-4 years regulatory experience, an understanding of regulatory compliance, medical terminology and technical writing experience preferred

· Experience in preparation and submission of appropriate documents to the IRB , including new study applications, continuing reviews, amendments, informed consent, revisions, adverse events, and report forms.

· Experience teaching and training, ability to use creative and effective presentation skills to teach groups of 4-80 adults

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

oeo@utah.edu

Online reports may be submitted at oeo.utah.edu

For more information: https://www.utah.edu/nondiscrimination/

To inquire about this posting, email: employment@utah.edu (%20employment@utah.edu) 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.