University of Utah PS Study Coordinator in Salt Lake City, Utah

Details

Open Date 06/21/2018

Requisition Number PRN17589B

Job Title Study Coordinator

Working Title PS Study Coordinator

Job Grade D

FLSA Code Administrative

Patient Sensitive Job Code? Yes

Standard Hours per Week 40 hrs/wk

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Monday – Friday

9:00 a.m. to 5:30 p.m.

Occasional weekend and after hours required.

VP Area U of U Health - Academics

Department 01643 - CLINICAL TRIALS OFFICE

Location Other

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $31,600 to $51.699 DOE

Close Date

Open Until Filled Yes

Job Summary

The Clinical Trials Office at University of Utah School of Medicine has an immediate opening for a Study Coordinator. The Study Coordinator coordinates technical and administrative details involved in clinical research studies, including Phase I – IV Clinical Trials, and assists Principal Investigators in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures.

Responsibilities

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 toIRBand 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.Maintains documents as required byFDAguidelines.

9.Maintains contact withIRBand prepares and submitsIRBdocuments.

10.Ensures proper collection, processing and shipment of specimens.

11.Ensures uTRAC and any other University or departmental required tracking database is maintained.

12.Performs additional clinical research functions and assists research team members as required.

Minimum Qualifications

Bachelor’s degree in a related field, or equivalency required.IRBCITICourse 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.

Some departments may requireIATADGRtraining within six months.

This position is patient sensitive and must fulfill all associated requirements.

Preferences

Two years of professional clinical research experience strongly 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”). 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.