Clinical Research Coordinators (Non-R.N.)

Clinical Research Coordinators (Non-R.N.)

Job Summary

The Division of Pediatric Endocrinology in the Department of Pediatrics at the University of Utah Spencer F. Eccles School of Medicine is seeking a Clinical Research Coordinator to support clinical research studies focused on improving outcomes for children and adolescents with endocrine disorders, including diabetes, growth disorders, and rare endocrine conditions.

Under the direction of the Principal Investigator and Clinical Research Manager, this position coordinates day-to-day research activities in accordance with study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements. Responsibilities include participant recruitment, screening, informed consent, study visit coordination, data collection and entry, maintenance of study documentation, adverse event reporting, regulatory support activities, and preparation for monitoring visits and study audits.

The Clinical Research Coordinator works closely with research participants and families, investigators, sponsors, and institutional partners to facilitate study operations, promote participant engagement, and ensure the collection of high-quality research data. This role contributes to the successful execution of clinical trials and the advancement of innovative treatments for pediatric endocrine disorders.

Department Summary

The Department of Pediatrics is the second largest department in the University of Utah School of Medicine and one of the largest pediatric departments in the country. We are committed to improving the lives of children through excellence in advocacy, education, research, and clinical care. For more information about the Department of Pediatrics, please visit: http://medicine.utah.edu/pediatrics/. Mutual respect and appreciation are highly valued in the department.

Benefits Summary

The University of Utah offers a comprehensive benefits package including:

• Excellent health care coverage at affordable rates (see the Summary Comparison for more information)
• 14.2% retirement contributions
• Generous paid leave time
• 11 paid Holidays per year
• 50% tuition reduction for employees, spouses, and dependent children
• Flex spending accounts
• University provided basic employee life insurance coverage equal to a salary of up to $25,000
• Variety of elective insurance coverage, including life insurance, short and long-term disability, accidental death & dismemberment, accident, critical illness, hospital indemnity, and pet.
• Free transit on 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 at https://benefits.utah.edu/.

Employee Health Requirements

This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. 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.

Responsibilities

Essential Functions:

Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. Implement processes and organize efforts within study team to achieve objectives, coordinating research procedures, study visits, and follow-up care. Create and maintain tools and documentation to track study metrics, providing updates to management. Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities. Maintain source documents and report adverse events. Recruit, screen, enroll, and obtain consent from study participants. Collect and maintain patient and laboratory data. Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies. Work under the direction of the Primary Investigator (PI).

1. Assist with clinical trial recruitment for several ongoing trials.
2. Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research conduct, including pre-screening and recruiting participants, scheduling visits, obtaining informed consent, answering participant/parent inquiries, performing study visit procedures (such as phlebotomy) and/or coordinating collection of study visit procedures with external departments, overseeing study visits and acting as a liaison between participants and study-related parties.
3. Recognizes, tracks and reports adverse events and protocol deviations.
4. Prepares for and coordinates site visits made by monitors, sponsors or federal agencies during course and at the close of the study.
5. Represents the research program at local meetings.
6. May assist with the preparation and submission of IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
7. Contributes to the development of source documentation, both paper and electronic.
8. Educates the community and other research professionals regarding ongoing trials.
9. Oversees compliance to protocol; manages quality control, completion and submission of study related documentation.
10. Develops and maintains record of trial participation including investigational logs, IP administration, medical devices monitored and/or procedures followed.
11. Ensure appropriate laboratory samples are collected and resulted either locally, or shipped out, and results are reported to the proper entities.
12. Completes ongoing training pertinent to best practices for clinical research coordination, FDA Good Clinical Practices (GCP), and clinical research standard operating procedures to ensure compliance with institutional and department policy and procedure, research sponsors and Federal rules and regulations.

Clinical Research Coordinator (Non-R.N.), I

Requires basic skill set and proficiency. Conduct work assignments as directed. Closely supervised with little latitude for independent judgment.

Requires a bachelor’s (or equivalency) with up to 2 years of directly related work experience or a master’s (or equivalency) degree.

This is an Entry-Level position in the General Professional track.

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.

Minimum Qualifications

EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor’s degree = 4 years of directly related work experience).

Department may hire employee at one of the following job levels:

Clinical Research Coordinator (Non-R.N.), I: Requires a bachelor’s (or equivalency) with up to 2 years of directly related work experience or a master’s (or equivalency) degree.

Preferences

• Strong preference will be given to candidates with medical assisting, phlebotomy and/or IV placement experience.
• Prior experience working with children.
• Experience with human subjects research and demonstrated human relations skills.
• Working knowledge of Good Clinical Practices, FDA, ICH, and IRB regulations and regulatory compliance.
• Must be a self-starter with critical thinking skills, exceptional organizational skills, ability to function independently, and strong attention to detail.
• Ability to work cooperatively within a team.
• Excellent interpersonal and communications skills, both oral and written.
• Proficiency in Microsoft Office and the ability to learn new software programs.
• IRB CITI Course for Human Subjects, CITI GCP, IATA DGR training and Bloodborne Pathogens Training are required within 3 weeks of hire.

The Department will screen applicants according to the identified preferences.

Work Schedule Summary

Monday – Friday, 8:00 a.m. – 5:00 p.m. with rotating weekend shifts possible as determined by operational needs.

Opportunities for a hybrid telework schedule may be considered after the initial training period, provided the arrangement is supported by operational needs and individual performance. Telework arrangements are not guaranteed and may be modified or discontinued at any time based on business requirements or performance. Employees approved for hybrid telework must provide their own private workspace, secure internet connection, and demonstrate the ability to work independently.

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 possess a strong commitment to improving access to higher education.

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.

Consistent with state and federal law, the University of Utah 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 Title IX (OEO). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at the: University of Utah Non‑Discrimination page.

Online reports may be submitted at https://oeo.utah.edu.

https://publicsafety.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.

As per University of Utah policy 5-108: Transfer of Benefits Eligible Staff Members, a new hire to the University of Utah who is still serving a 12 month probationary period will not be hired into another University of Utah job (a transfer) until the successful completion of the probationary period.