Job Information

University of Utah PS Clinical Research Coord in Salt Lake City, Utah

Open Date 10/26/2021

Requisition Number PRN28130B

Job Title PS Clinical Research Coord

Working Title PS Clinical Research Coord

Job Grade E

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

VP Area U of U Health - Academics

Department 00224 - Internal Medicine Admin

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 39300 to 72700

Close Date

Open Until Filled Yes

Job Summary

Internal Medicine (IM) seeks an experienced Clinical Research Coordinator to join its Clinical Trials Unit. The successful candidate will coordinate the implementation and completion of research studies while assisting Principal Investigators in determining and accomplishing study objectives. Oversees research studies from an administrative and operational perspective while maintaining compliance with guidelines set by governing agencies and the University of Utah.

Responsibilities

1. Oversees compliance with study protocols; manages quality control, completion and submission of study related documents.

2. Monitors study enrollment goals and promotes enrollment and participant compliance. Develops informed consent and screening materials, screens and recruits subjects, schedules visits, obtains informed consent, answers participant questions, oversees study visits including the collection and shipment of study samples, and acts as a liaison between participants and other study-related parties.

3. Prepares, submits and maintains IRB , FDA , and/or other regulatory applications, documents and research correspondence. Recognizes, tracks and reports adverse events and deviations per protocol requirements, and institutional and federal guidelines.

4. Prepares for and coordinates sponsor site visits. Works with the sponsor representative/ monitor to make corrections, resolve issues, implement process improvement, etc.

5. Develops and maintains patient databases, investigational logs and records of study treatment administered, and/or procedures followed.

6. With assistance from IM Research Administration staff, develops study budgets and negotiates payment schedules with sponsors. Monitors budget expenses and billing for related services.

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

Bachelors degree in a health sciences or related field with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.

Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.

Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.

Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.

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.

Preferences

1. University of Utah related research experience

2. Knowledge of Good Clinical Practices, IATA Dangerous Goods, FDA , HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently preferred

3. Requires completion of IM Clinical Research Training Program within two months of hire

4. Requires completion of the IRB -required Human Subjects Research and Good Clinical Practice training courses within 2 weeks of start date.

Type Benefited Staff

Special Instructions Summary

Additional Information

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

Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are 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:

Director/ Title IX Coordinator

Office of Equal Opportunity and Affirmative Action ( OEO /AA)

135 Park Building

Salt Lake City, UT 84112

801-581-8365

oeo@utah.edu

Online reports may be submitted at oeo.utah.edu

For more information: https://www.utah.edu/nondiscrimination/

To inquire about this posting, email: employment@utah.edu (%20employment@utah.edu) or call 801-581-2300.

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.