University of Utah Study Coordinator in Salt Lake City, Utah84165

Details

Open Date 11/08/2016

Requisition Number PRN12834B

Job Title Study Coordinator

Working Title Regulatory Study Coordinator

Job Grade D

FLSA Code Administrative

Patient Care Job Code? No

Standard Hours per Week 40 hrs/wk

Full Time or Part Time?

Shift

Work Schedule Summary

Monday – Friday

8:00 a.m. to 5:00 p.m.

VP Area Health Sciences

Department 01643 - CLINICAL TRIALS OFFICE

Location

City

Type of Recruitment External Posting

Pay Rate Range $31,600 to $51,699 DOE

Close Date

NOTE: May close at anytime.

Open Until Filled

NOTE: May close at anytime. Yes

Job Summary

The Clinical Trials Office at the 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 regulatory requirements for Phase I – IV Clinical Trials, and assists Principal Investigators and regulatory coordinators in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures. This position will work with research and regulatory staff utilizing federal and institutional guidelines.

The University of Utah offers an exceptional benefits package, a wellness program, and competitive salary commensurate with experience. Mutual respect and appreciation are highly valued within the University.

Responsibilities

1.Assesses protocol for clarity, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and assists with participant recruitment plans and materials.

2.Supports all aspects of regulatory compliance.

3.Advises research team regarding specific study assignments and timelines.

4.Tracks study approvals and expirations to ensure uninterrupted project approval.

5.Determines length of visits and coordinates related facility and equipment availability for sponsor visits with PI and any requested study staff.

6.Reports and tracks adverse events (AE). Reports serious AEs toIRBand sponsor.

7.Completes, audits, corrects CRFs, relays CRFs to study team.

8.Maintains documents as required byFDAguidelines

9.Maintains contact withIRBand prepares and submitsIRBdocuments.

10.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.

Preferences

Professional research experience strongly preferred. This position should have working knowledge of federal and institutional regulatory requirements.

Applicants will be screened according to 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.