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

Details

Open Date 06/12/2018

Requisition Number PRN17445B

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

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Monday – Friday, 8:00 am – 5:00 pm

VP Area U of U Health - Academics

Department 00853 - Pediatric Endocrinology

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $31,600 to $40,000

Close Date

Open Until Filled Yes

Job Summary

The Department of Pediatrics at the University of Utah School of Medicine has an immediate opening for a Study Coordinator to provide support to the research team and Principal Investigators in the Division of Pediatric Endocrinology. The Study Coordinator is responsible for coordinating the technical and administrative details involved in multiple research studies, as well as assisting the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures. Responsibilities include: assessing eligibility criteria; interfacing with providers, patients and their families; obtaining informed consent; conducting study visits; collecting and recording study data into variousEDCsystems as determined by specific projects; and preparing regulatory documentation. Cross-training to provide coverage for other trials and services supported by the division may be required.

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 with related facility and equipment availability.

5.Recognizes, tracks and reports 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.May maintain contact withIRBand prepare and submitIRBdocuments.

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

11.May perform functions required of the Clinical Research Assistant as necessary.

12.Oversees compliance to study protocols, as defined by on-going and projected trials; manages quality control, completion and submission of study related documentation; prepares reports for research manager, Principal Investigators and sponsors, as requested.

13.Disseminates information about protocols to diabetes clinic staff where applicable.

14.Assists with preparation and coordination of site visits made by CROs, sponsors and/or federal agencies during the course of and at the close of the study.

15.Assures proper laboratory samples are collected and results are reported to the proper entities.

16.Attends all appropriate meetings as determined by the Principal Investigator and Pediatric Endocrinology Research Manager.

17.Cross-trains to provide coverage for existing research staff.

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

Excellent interpersonal and communications skills, both oral and written. Proficiency in Microsoft Office and ability to learn new software programs. Exceptional ability to quickly prioritize tasks in a dynamic environment, strong organizational skills and attention to detail. Ability to function independently is preferred.

Prior knowledge of Good Clinical Practice, blood borne pathogens and shipping category B substances, or willing to complete training within 6 months of hire.

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.