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

Details

Open Date 08/24/2018

Requisition Number PRN18186B

Job Title Pediatric Project Manager I

Working Title Pediatric Project Manager I

Job Grade E

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, daytime hours

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 $39,300 - $64,349

Close Date

Open Until Filled Yes

Job Summary

Under the guidance of the Program Manager, manages and coordinates research network studies and trials at various clinical sites. Monitors the conduct and progress of studies to ensure compliance with established protocols and study timelines. May assist in the development of research projects, scientific study design, data interpretation, training of research site personnel, and maintain regulatory compliance, patient safety, and data quality.

Licensed professionals may perform medical reviews and analyze or evaluate clinical data.

Responsibilities

Essential Functions

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

2.Prepares, submits, and maintainsIRB,FDA, and other regulatory documents and research correspondence.

3.Reviews site files and records for completeness, accuracy, consistency and compliance; identifies deficiencies or discrepancies and facilitates their resolution

4.Assures that adverse events are reported to the sponsor

5.Works with programmers to develop and test databases and other collection tools

6.Analyzes incoming data to identify trends, problems, or other issues

7.Prepares and interprets reports and queries for Investigators and Research Coordinators, which include, but not limited to monthly enrollment reports, reports of various data elements, query reports, etc.

8.Ensures that captured data is accurate and corrects erroneous or conflicting data

9.Communicates with study sites frequently to discuss and follow-up on data issues and troubleshoots possible solutions.

10.Works with site monitors to ensure protocol and regulatory compliance, data quality, and patient safety

11.Performs remote monitoring of site data in coordination with appropriate personnel

12.Attends required meetings and conferences as appropriate

13.Licensed professionals may be assigned medical reviews

Problem Solving

May provide input on site performance, compliance and data quality

Comments

Day to day challenges include: helping remote research sites enroll patients successfully, providing guidance and assuring compliance withIRBstandards, the protocol, and national clinical research regulations.

Disclaimer

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 equivalencyAND2 years of clinical research experience. Experience with human subjects research preferred. Must have excellent interpersonal and communication skills, both oral and written. Must be proficient in Microsoft Office and possess the ability to learn new software programs.

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.

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.