University of Utah Study Coordinator in Salt Lake City, Utah
Open Date 10/13/2017
Requisition Number PRN15494B
Job Title Study Coordinator
Working Title Study Coordinator
Job Grade D
FLSA Code Administrative
Patient Care Job Code? No
Standard Hours per Week 40
Full Time or Part Time? Full Time
Work Schedule Summary
Monday – Friday, 8:30 am – 5:00 pm.
VP Area U of U Health - Academics
Department 01714 - DVSN OF ALLERGY & IMMUNOLOGY
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $31,600 to 45,000 DOE
NOTE: May close at anytime.
Open Until Filled
NOTE: May close at anytime. Yes
Coordinates technical and administrative details involved in research studies and clinical trials. 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.Assists PI in performing oral food challenges; monitors for AEs including allergic symptoms.
3.Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines.
4.Explains and obtains informed consent, medical history, allergy and dietary (food allergen exposure) history, and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.
5.Determines length of visits and coordinates related facility and equipment availability.
6.Reports and tracks adverse events (AE). Reports serious AEs toIRBand sponsor.
7.Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
8.Completes, audits, corrects CRFs, relays CRFs to sponsor.
9.Maintains documents as required byFDAguidelines.
10.Maintains contact withIRBand prepares and submitsIRBdocuments.
11.Ensures proper collection, processing and shipment of specimens.
12.Performs functions required of the Clinical Research Coordinator as necessary.
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.
•Knowledge of Good Clinical Practices,FDA,HIPAAandIRBregulations
•Understanding of research procedures
•Attention to detail
•Ability to function independently
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: email@example.com 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: firstname.lastname@example.org .
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.