University of Utah Study Coordinator in Salt Lake City, Utah
Open Date 11/12/2020
Requisition Number PRN24732B
Job Title PS Study Coordinator
Working Title Study Coordinator
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
Monday – Friday, 9:00 a.m. – 5:30 p.m., some weekends and after hours.
VP Area U of U Health - Academics
Department 01643 - CLINICAL TRIALS OFFICE
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $31,600 - $51,699
Open Until Filled Yes
Coordinates technical and administrative details involved in a clinical or research study. Assists the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures.
1. Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with 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. Determines length of visits and coordinates related facility and equipment availability.
5. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
6. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
7. Completes, audits, corrects CRFs, relays CRFs to sponsor.
8. Assists with negotiating contract budget and payment terms.
9. Maintains documents as required by FDA guidelines.
10. Maintain contact with IRB and prepare and submit IRB documents.
11. Ensure proper collection, processing and shipment of specimens.
12. Perform functions required of the Clinical Research Assistant as necessary.
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.
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.
Previous clinical research experience. Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of research procedures; attention to detail; and the ability to function independently is preferred. Excellent interpersonal and communications skills, both oral and written. Proficiency in Microsoft Office and ability to learn new software programs.
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.
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.