Details

Open Date 07/08/2024

Requisition Number PRN39119B

Job Title PS 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 a.m. – 4:30 p.m. (hours may vary)

VP Area U of U Health - Academics

Department 00848 - Pediatric Administration

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $31,600 to $55,621

Close Date

Open Until Filled Yes

Job Summary

Job Summary:

The division of Pediatric Rheumatology at the University of Utah School of Medicine has an immediate opening for a Study Coordinator. The Study Coordinator will assist with operation and coordination of human subjects research studies under the direction of a senior research coordinator or manager. Coordinates technical and administrative details involved in research studies and clinical trials, and assists the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures.

The University of Utah offers a comprehensive benefits package including:

• Excellenthealth care coverageat affordable rates

• 14.2% retirement contributionsthat vest immediately

• Generouspaid leave time

• 11 paid Holidaysper year

• 50% tuition reductionfor employee, spouse, and dependent children

• Flex spending accounts

• Free transiton most UTA services

• Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel

• Professional development opportunities

Additional benefits information is available atwww.hr.utah.edu/benefits

Responsibilities

Essential Functions:

1. Collects and compiles data from a variety of sources; may enter data into a PC or computer terminal. Enters data into electronic data capture systems/databases/spreadsheets, and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.

2. Assists senior research coordinator in identifying potential study participants and may assist in explaining and obtaining informed consent.

3. Maintains supply inventory, including ordering supplemental test articles and returning unused test articles to sponsor.

4. Assists in the preparation and maintenance of regulatory documents as required by FDA guidelines.

5. Determines visit windows from protocol, schedules subject visits and sends visit reminders. Determines length of visits and coordinates related facility and equipment availability. Ensures study visits and procedures do not conflict with existing schedules. Coordinates study visits between participants and clinic staff.

6. Attends and participates in Investigator and staff meetings. Assists team with specific study assignments and timelines.

7. Assists in reporting and tracking adverse events (AE). Reports serious AEs to IRB and sponsor.

8. Assists in proper collection processing and shipment of lab specimens according to protocol directions.

9. Completes, audits, corrects CRFs, relays CRFs to sponsor.

10. May maintain contact with IRB and prepare and submit IRB documents.

11. Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.

12. 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.

13. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.

Disclaimer:

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Work Environment and Level of Frequency typically required

Nearly Continuously: Office environment.

Seldom: Infectious disease, exposure to animals, oils (there is air or skin exposure to oils or other cutting fluids)

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.

Minimum Qualifications

Bachelor’s degree in a related field, or equivalency (one year of education can be substituted for two years of related work experience) 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.

Preferences

Preferences:

• Phlebotomy skills/certification.

• Previous clinical research experience.

• Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations.

• 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.

• Previous work on the Childhood Arthritis and Rheumatology Research Alliance ( CARRA ).

• Previous work on the Observational Registry of Abatacept in patients with JIA .

• Previous work on the project Using the Cholinergic Anti-Inflammatory Pathway to Treat JIA (tcVNSin JIA )-AJA01.

Applicants will be screened according to department preferences.

Type Benefited Staff

Special Instructions Summary

Additional Information

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 of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.

All qualified individuals are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.

The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.

To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action ( OEO /AA). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/

Online reports may be submitted at oeo.utah.edu

https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.