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

Details

Open Date 06/16/2017

Requisition Number PRN14504B

Job Title Pediatric Project Manager II

Working Title Pediatric Project Manager II

Job Grade F

FLSA Code Administrative

Patient Care Job Code? No

Standard Hours per Week 40 hrs/wk

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Monday – Friday

8:00 a.m. to 5:00 p.m.

VP Area Health Sciences

Department 00850 - Pediatric Critical Care

Location Other

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $47,600 to $79,699 DOE

Close Date

NOTE: May close at anytime.

Open Until Filled

NOTE: May close at anytime. Yes

Job Summary

The Division of Pediatric Critical Care at the University of Utah School of Medicine has an immediate opening for a Pediatric Project Manager II. This is an exciting opportunity to serve as a Project Manager for theNIHfunded Utah Trials Innovation Center (TIC). TheTICis part of an initiative to create the Trial Innovation Network as part of the Clinical and Translational Science Award (CTSA) Program. This position provides opportunities to work with a high functioning, cutting edge team that will study, understand and improve multi-site translational research. This position requires a person with autonomy, creativity, and critical thinking skills.

The Pediatric Project Manager II independently manages and coordinates 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 time lines. Licensed professionals may perform medical reviews and analyze or evaluate clinical data. This position provides the opportunity to travel for network committee meetings.

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

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 ofFDA,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”). 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.