University of Utah PS Manager, Clinical Research in Salt Lake City, Utah

Details

Open Date 02/27/2019

Requisition Number PRN19730B

Job Title PS Manager, Clinical Research

Working Title PS Manager, Clinical Research

Job Grade G

FLSA Code Administrative

Patient Sensitive Job Code? Yes

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Monday-Friday 8:30 a.m. – 5:00 p.m.

VP Area U of U Health - Academics

Department 00268 - Neurosurgery

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 65000 to 95000

Close Date

Open Until Filled Yes

Job Summary

Under minimal supervision, responsible for planning, organizing, directing and/or controlling all aspects pertaining to clinical research functions of assigned department’s internal and external customer service, human resource and financial management operations pertaining to areas including (but not limited to) clinical data, standardization, statistical analysis, monitoring clinical trials, and development and completion of clinical studies. Acts as a catalyst between the department and its customers and staff to ensure continuity and quality of service and care. This position is located at Primary Children’s Hospital.

Responsibilities

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

2. Assumes considerable leadership responsibilities of studies throughout the network.

3. Assures regulatory compliance for the data coordinating center.

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

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

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

7. Assures that adverse events are reported to the sponsor.

8. Develops study specific network guidelines and Standard Operating Procedures.

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

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

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

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

13. Performs site monitoring activities independently.

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

15. Develops departmental strategies consistent with the assigned departments continuous quality improvement program.

16. Ensures competency of staff through the development and/or presentation of educational programs and through on going staff performance evaluations.

Minimum Qualifications

Bachelor’s degree in a related area or equivalency (2 years related work experience may be substituted for 1 year of education). Four to six years of progressively more responsible management experience. Background knowledge of hiring department’s area of specialization in order to analyze, plan and draw conclusions for recommendations to superiors. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop subordinates and to ensure the smooth operation of department.

This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according toCDCstandards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

Master’s degree in a related area may be preferred.

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 priorURSservice, may elect to enroll inURSif 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 fromURSare 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.