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

Open Date 08/27/2020

Requisition Number PRN24193B

Job Title PS Clinical Research Coord

Working Title 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

8:00 to 5:00; some flexibility in hours is possible.

VP Area U of U Health - Academics

Department 00958 - DFPM-Administration

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $48,000/yr DOQ

Close Date

Open Until Filled Yes

Job Summary

Coordinates the implementation, quality control and completion of a COVID -19 study funded by the Centers for Disease Control and Prevention ( CDC ). Assists the Principal Investigator (PI) in establishing and accomplishing study objectives, and ensures recruitment and follow-up of the study participants throughout the course of the studies. Oversees study management, including administrative, personnel and technical functions of the research programs. Obtains participant consent and reports and tracks adverse events and protocol deviations. Applies statistical analyses to research projects for the purpose of effectively collecting and reporting data. Is involved in the writing of manuscripts and grants. Assists in critiquing the literature, conducting quality checks, and grading the body of evidence. Organizes site visits made by sponsors.

This position is considered Category IIA : Not required on campus and has the ability to telework remotely for the duration of the University of Utah’s response to COVID -19. An employee hired into this role will be responsible for providing space, telephone, printing, networking and/or internet capabilities at the telecommute location and agree to the terms of the University of Utah campus and Health Academics COVID -19 Telecommuting Agreement.

Responsibilities

Essential Functions

1. Prepares, submits, and maintains IRB , CDC , NIOSH and other regulatory documents and research correspondence.

2. Monitors protocol compliance and audits documentation for completeness and accuracy.

3. Supervises and trains research personnel (2-4 research assistants)

4. Assists in the development of research protocols, policies and procedures for the research site as well as educational materials and scientific publications.

5. Coordinates site visits made by sponsors during the course of and at the close of the study.

6. Coordinates and performs responsibilities related to research participants, including recruiting subjects, scheduling visits, screening subjects, obtaining informed consent, and overseeing study visits.

7. Assists in coordinating data collection and compiling study data from the other Universities to analyze the data for the entire study at the University of Utah.

8. Recognizes, tracks, and reports adverse events and protocol deviations.

9. Modifies protocols to prevent further deviations or adverse events.

10. Develops and maintains informational databases regarding study protocol and patient data.

11. Follows up with study participants and acts as the liaison between physicians, sponsors, patients, employers, and others associated with the study.

12. Assists in performing calculations to ensure the correctness and appropriateness of the results.

13. Utilizes existing statistical or mathematical routines, or develops programs for new techniques so that appropriate analysis of study data may be performed.

14. Communicates technical electronic problems/solutions to investigators and research directors in technical or non-technical languages as to be understood.

15. Assists in maintaining all details associated with the process of research studies and assists investigators in establishing and accomplishing study objectives.

16. Contacts potential study subjects to determine their eligibility based on protocols (screening, enrollment, consent forms, and questionnaires).

17. Encourages strong candidates to participate in the study and secures health history information.

18. Assists in maintaining study records and documents in compliance with protocols and federal, state, and University regulations and guidelines.

19. Assists in facilitating communication regarding study procedures and results with research participants, referring physicians, and other researchers.

20. Oversees on-site study activities to ensure the effective follow-through of study protocols.

21. Designs documents and devices to expedite data collection.

22. Writes computer programs to perform electronic administration of questionnaires and structured interviews.

23. Assists in maintaining validity of data and test results; verifies accuracy of data.

24. May assist PI in exploring the possibility of initiating study activities at other sites.

25. Coordinates with other study sites to solve problems and ensure uniformity of data collection and study performance.

26. Counsels patients and other participants on study requirements and answers questions.

27. Assists in the preparation of a study budget and allocates assets.

28. Arranges for appropriate medical training such as CPR , phlebotomy, etc.

29. Monitors the appropriate processing of samples such as blood. Will travel locally throughout Utah to obtain samples for evaluation.

Problem Solving

The incumbent decides how to best accomplish the daily requirements of the epidemiological studies, determines workload, prioritizes, delegates and establishes systems needed to achieve specific study goals. Efforts of multiple departments and disciplines must be coordinated to ensure the effective follow through of the studies and compliance of all involved. The incumbent functions independently under minimal supervision, following NIOSH , CDC , IRB and other regulatory agency guidelines and seeking council from the Principal Investigator as necessary. They also have responsibility to train, evaluate performance and make salary recommendations for support staff. They may participate in preparing the study budget by making salary and supply recommendations. This position makes independent decisions when overseeing and conducting details involved with studies; however, the development of protocols and procedures is a collaborative effort with the PI. Incumbents may act as an advocate for the particular studies to the public and agencies. The incumbent is often challenged to determine the most effective training needed for staff in order to ensure the most accurate information is being gathered. The development of new studies requires him/her to have an in-depth knowledge of scientific principles in order to recommend an alternative direction. The incumbent must be able to assess the most effective use of dollars and staff hours. He/she analyzes the potential benefits vs. allocation of assets. Another challenge is being able to respond with judgment and diplomacy to a patient’s request for information, as that may jeopardize the confidentiality of another participant or introduce bias into the study. The incumbent in this position assists in overseeing the activities of support staff members, collaborates research activities of research teams and participates in the administration of study budgets.

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

A Master’s of Science degree in public health or related field or equivalency; two years of direct scientific research in occupational medicine research or study coordination related experience; and familiarity with theoretical and practical non-standard statistical techniques required. Working knowledge of computer systems and demonstrated human relation and effective communication skills required. Extensive experience in analytical methods to include qualitative and quantitative analysis of cross sectional, case-control, and cohort data. Knowledge regarding Center for Disease Control and Prevention ( CDC ), and Institutional Review Board ( IRB ) requirements. Experience with preparing and managing budgets, supervisory experience, and research methodology are required. Experience conducting exhaustive literature searches and summarizing randomized controlled trials required. Experience with best practice guideline construction required. Knowledge of SAS and STATA statistical software programs and Endnote citation software are also required. A strong epidemiological and statistical background is preferred.

Type Benefited Staff

Special Instructions Summary

Clinical Research Coordinator: Requires B.S. degree or foreign equivalent in public health or related field; previous experience conducting scientific or clinical research; experience with practice guideline formulation and research. Responsibilities include oversee management, implementation and completion of multiple large population based epidemiological research studies. Assists in establishing and accomplishing study objectives, ensure recruitment and follow-up of study participants throughout the course of the studies. Applies statistical analyses to research projects for the purpose of effectively collecting and reporting data.

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”). 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 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.

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