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University of Utah Pediatric Project Manager II in Salt Lake City, Utah

Open Date 10/16/2020

Requisition Number PRN24551B

Job Title Pediatric Project Manager II

Working Title Pediatric Project Manager II

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 – Friday

VP Area U of U Health - Academics

Department 00850 - Pediatric Critical Care

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $47,600 - $79,699

Close Date

Open Until Filled Yes

Job Summary

Independently manages and coordinates Pediatric Emergency Care Applied Research Network ( PECARN ) research network studies and trials at various clinical sites. Assists in the development of research projects, scientific study design, data interpretation, training of research site personnel, and maintains regulatory compliance, patient safety, and data quality. Monitors the conduct and progress of studies to ensure compliance with established protocols and study timelines. Licensed professionals may perform medical reviews and analyze or evaluate clinical data.

PECARN is the first federally-funded multi-institutional network for research in pediatric emergency medicine in the United States. The goal of this network is to conduct meaningful and rigorous multi- institutional research into the prevention and management of acute illnesses and injuries in children and youth across the continuum of emergency medicine health care. www. PECARN .org

The University of Utah offers a comprehensive benefits package with excellent health care choices, retirement plans and paid leave time. Current benefit information is available at www.hr.utah.edu/benefits.

Responsibilities

1.Independently provides oversight for all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institution level.

2.Assures regulatory compliance for the data coordinating center

3.Maintains research data files and regulatory documents for all clinical trial sites.

4.Identifies and creates queries to improve data capture and assists in developing methods to clarify/clean existing data

5.Reviews site monitoring reports and discusses findings with Study Investigators and offers suggestions and solutions to problems, concerns, or recurrent trends or themes

6.Assures that adverse events are reported to the sponsor

7.Reviews site records for accuracy regarding test article accountability

8.Develops study specific network guidelines and Standard Operating Procedures

9.Organizes study trainings and gives presentations to employees and other research coordinators on good clinical practices and study procedure implementation

10.Acts as liaison between study Investigators and sponsors to communicate and resolve issues

11.Assumes considerable leadership responsibilities of studies throughout the network

12.Provides feedback on study site performance, compliance, and data quality

13.Makes recommendations regarding site disciplinary actions, which may result in site monitoring visits, suspension, or discontinuation of a study site

14.Performs remote site monitoring activities independently

15.Licensed professionals may be assigned medical reviews

16.Must be able to perform the essential functions of a Level 1 Project Manager

This job description 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.

Minimum Qualifications

Bachelor’s degree in a health science field, or equivalency (2 years related work experience may be substituted for 1 year of education). 4 years of clinical research experience that includes project management is also required. Experience with human subjects research, good leadership skills, and working knowledge of FDA , ICH , and other regulatory compliance are also required. Must have excellent interpersonal and communications skills, both oral and written. Must be proficient in Microsoft Office and possess the ability to learn new software programs such as electronic data capture software.

Credentialing as a Certified Clinical Research Coordinator ( CCRC ), Certified Clinical Research Professional ( CCRP ), Certified Clinical Research Associate ( CCRA ) or other related certification is highly preferred, along with experience in the specific clinical research area.

Depending on the area of assignment, current medical licensure may be preferred. Licensed professionals must have a current registration or licensure in the State of Utah as required by the profession.

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

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”). 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 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.

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