Job Information

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

Open Date 07/26/2021

Requisition Number PRN27082B

Job Title Pediatric Project Manager III

Working Title Pediatric Project Manager III

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 through Friday, 8:00 a.m. to 5:00 p.m.

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 to $79,699

Close Date

Open Until Filled 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 III . This is an exciting opportunity to serve as a Project Manager for the Data Coordinating Center at the University of Utah. In this position, there are opportunities to work with a high functioning, cutting-edge team that will study, understand and improve multi-site research. This position desires a person with a strong clinical research background, protocol development experience as well as regulatory experience in working with single IRBs. Autonomy, creativity, and critical thinking skills are strongly encouraged. Project Managers for the Data Coordinating Center will manage multicenter clinical trials, coordinate network consultations, and manage single IRB activities for assigned projects.

This position will support more than one research network and research projects that may include: pediatric emergency department trials in the Data Coordinating Center funded by the PECARN Network ( www.pecarn.org ), the Trial Innovation Network, one of only 3 in the country, the Network of Pediatric Multiple Sclerosis Centers ( NPMSC ) and the Guthy Jackson Charitable Foundation, a research network addressing Neuromyletis Optica. This position may also support new, exciting, incoming research projects our business development core. This is a well-rounded position with exposure to a variety of exciting research in both pediatrics and adults. The Project Manager role is at the center of the activity of each project, working with sites, investigators and researchers. This role also offers autonomy, energy, interaction with interesting people and the opportunity to be involved in interesting, impactful research.

The Department of Pediatrics has a defined career ladder for Project Managers and provides growth and professional development opportunities.

The University of Utah offers a comprehensive benefits package with extensive healthcare options, 14.2% retirement contributions that vest immediately, and paid time off. Current benefit information is available at www.hr.utah.edu/benefits .

Responsibilities

  1. Assists network clinical investigators and research coordinators with the development of scientific research projects and oversees protocol development
  2. Works with investigators to design data collection tools and other data elements.
  3. Prepares, submits, and maintains regulatory documents and research correspondence
  4. Assesses quality patient safety issues related to the data and develops intervention plans as necessary
  5. Conducts site monitoring visits or assists with visits to clinical sites to ensure protocol and regulatory compliance, data quality, and patient safety
  6. Completes detailed reports of monitoring findings
  7. Analyzes and evaluates clinical data
  8. Licensed professionals may be assigned medical reviews
  9. Leads and mentors junior team members
  10. Assists Project Director with all orientation and training of new team members
  11. Must be able to perform the essential functions of level 1 and 2 Project Managers.

Problem Solving

This position makes independent decisions regarding data issues, study procedures and protocol issues as well as recognizing and resolving protocol deviations. It provides input on site performance, compliance and data quality. This position also makes recommendations for disciplinary action, which may result in a site monitoring visit, suspension or discontinuation of a study site. Determines when to involve Study Principal Investigator or DCC Principal Investigator about issues/concerns that arise at the study sites and develops methods to resolve data discrepancies.

Comments

This position requires expertise and interpretation of laws, federal regulations, ICH guidelines and Good Clinical Practice guidelines to provide direction/guidance/supervision to study sites. Ensures the sites are compliant with protocol, federal regulations, ICH guidelines, Good Clinical Practice guidelines and local IRB requirements.

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It 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, credentialing as a Certified Clinical Research Coordinator ( CCRC ), Certified Clinical Research Professional ( CCRP ), or Certified Clinical Research Associate ( CCRA ) or other related certification, AND 6 years clinical research experience that includes project management. Knowledge of FDA , ICH , and other regulatory guidelines, experience in writing research materials, excellent leadership skills, as well as excellent interpersonal and communication skills are also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs.

Preference will be given to candidates having a Master’s degree in a health related 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.

Preferences

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.