Clinical Research Coordinators (Non-R.N.)

Clinical Research Coordinators (Non-R.N.)

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.

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).

Learn more about the great benefits of working for University of Utah: benefits.utah.edu

The department may choose to hire at any of the below job levels and associated pay rates based on their business need and budget.

Job Summary

We invite applications to join the Neurotherapeutics Lab in the division of Health Systems Innovation and Research. We are looking for a colleague who is passionate about mental and cognitive health care of our participants, and has an interest in digital medicine. In this position, the CRC coordinates the implementation, quality control and completion of clinical trials while assisting the Principal Investigator in regulatory oversight, preparation of IRB documents, data collection, quality control, recruitment and retention of participants. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.

Qualifications

• Bachelor’s degree in a health sciences or related field with two years professional research experience.
• Exceptional organizational skills, attention to detail, and demonstrated professional maturity and effective communication skills are also required.
• Previous scientific writing, data analysis, and experience with multidisciplinary teams experience strongly preferred.
• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
• This position requires IRB CITI Course and/or IATA DGR training within a specified timeframe.
• 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.
• Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Responsibilities

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

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). 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.

Job Code: PZ6511
Grade: P11
Expected Pay Range: $24,722 to $56,715

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

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. Works under the direction of the Primary Investigator (PI). Requires moderate skill set and proficiency in discipline. Conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment.

Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience.

This is a Developing-Level position in the General Professional track.

Job Code: PZ6512
Grade: P13
Expected Pay Range: $29,913 to $68,625

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

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. Works under the direction of the Primary Investigator (PI). Considered highly skilled and proficient in discipline. Conducts complex, important work under minimal supervision and with wide latitude for independent judgment.

Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience.

This is a Career-Level position in the General Professional track.

Job Code: PZ6513
Grade: P15
Expected Pay Range: $36,196 to $83,036

Responsibilities

1. Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
2. Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
3. Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.
4. Recognizes, tracks and reports adverse events and protocol deviations.
5. Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
6. Represents the research program at meetings, national and international research consortia.
7. Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
8. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
9. Supervises, mentors and trains new or junior research staff.
10. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
11. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
12. Assists the Principal Investigator in the development of study protocols.

This job description 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 that may be required:
Nearly Continuously: Office environment.
Seldom: Infectious disease, 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: Hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking, standing, sitting.
Seldom: Bending, reaching overhead.

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.

Clinical Research Coordinator (Non-R.N.), II: Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience.

Clinical Research Coordinator (Non-R.N.), III: Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience.

Preferences

Applicants with master’s degree are strongly preferred.

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

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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.