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
Work Schedule Summary
Monday – Friday
VP Area U of U Health - Academics
Department 00850 - Pediatric Critical Care
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $47,600 - $79,699
Open Until Filled Yes
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.
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.
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.
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”). 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.