University of Utah Study Coordinator, PS in Salt Lake City, Utah
Open Date 02/25/2021
Requisition Number PRN25388B
Job Title PS Study Coordinator
Working Title Study Coordinator, PS
Job Grade D
FLSA Code Administrative
Patient Sensitive Job Code? Yes
Standard Hours per Week 40
Full Time or Part Time? Full Time
Work Schedule Summary
VP Area U of U Health - Academics
Department 00952 - Division of Epidemiology
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 31600 to 51699
Open Until Filled Yes
The study coordinator will be housed in the Division of Epidemiology’s Program for Addiction Research, Clinical Care, Knowledge and Advocacy ( PARCKA ). The position requires coordination of technical and administrative details involved in clinical trials research for substance use disorder studies. PARCKA’s studies are conducted at various clinics in the Salt Lake City area. Job duties will require interaction with study participants, investigators, clinic and research staff, and study monitors. The incumbent will work closely with the project team to achieve study integrity and objectives through the successful implementation and completion of protocols and procedures.
This position is considered Category IIA : Not required on campus and has the ability to telework remotely for the duration of the University of Utah’s response to COVID -19. An employee hired into this role will be responsible for providing space, telephone, printing, networking and/or internet capabilities at the telecommute location and agree to the terms of the University of Utah campus and Health Academics COVID -19 Telecommuting Agreement.
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.
1.Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with project manager, Principal Investigator and sponsor.
2.Attends and participates in investigator and staff meetings. Advises team regarding specific study assignments and timelines.
3.Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.
4.May travel to a variety of sites both within and outside the University campus to obtain data
5.May conduct research assessments, including structured assessments of sensitive topics with high-risk populations
6.Determines visit windows from protocol, schedules subject visits and sends visit reminders to help retain them in the study and prevent study attrition
7.Ensures study visits and procedures do not conflict with existing schedules
8.Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
9.Documents all protocol deviations, reconciles study supply accountability and may prepare summary reports for sponsors
10.Answers patient queries and maintains research records in compliance with regulations
11.Maintains documents as required by FDA guidelines.
12.May assist in IRB or other regulatory approval processes and documentation
13.May ensure proper collection, processing and shipment of specimens.
14.Performs functions required of the Clinical Study Assistant as necessary.
Incumbents are responsible for coordinating the daily operations of their assigned research team, coordinating the orderly and safe flow of the research project and maintaining adequate resources for the PI to accomplish their research objectives.
Several years of prior research experience is preferred.
Work Environment and Level of Frequency that may be required
Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking. Seldom: Bending, reaching overhead.
The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient’s status and provide care as described in the department’s policies and procedures manual.
Bachelor’s degree in a related field, or equivalency required. IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire and demonstrated human relations and effective communication skills are also required.
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 to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.
Some departments may require IATA DGR training within six months.
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: firstname.lastname@example.org 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: email@example.com .
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.