University of Utah Clinical Research Coord in Salt Lake City, Utah
Open Date 12/23/2020
Requisition Number PRN24979B
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
Work Schedule Summary
VP Area U of U Health - Academics
Department 00237 - Nephrology
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $39,300 to $64,000
Open Until Filled Yes
Coordinates the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.
This position is considered Category I: Mandatory and required on campus or health care facilities to support on-site operations. Employees hired into this category will be required to be physically located at the work site if they are healthy and without COVID -19 symptoms.
1. Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies. 10%
2. Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services. 10%
3. Reconciles study expenditures, generates participant tracking reports & study payment reports, submits sponsor invoices, and regularly meets with PI’s on study enrollment and financial status. 30%
4. 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. 20%
5. Recognizes, tracks and reports adverse events and protocol deviations. 3%
6. Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study. 3%
7. Represents the research program at meetings, national and international research consortia. 2%
8. Prepares, submits and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence. 10%
9. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues. 2%
10. Supervises, mentors and trains new or junior research staff. Manage staff schedules ensuring shift/studies are covered; approve requests for time off/approve Kronos. 5%
11. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed. 5%
The incumbent decides how to best accomplish the daily requirements of various study objectives, prioritizes and delegates workload and establishes systems needed to achieve specific study goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved. The incumbent functions independently under minimal supervision, following FDA , Good Clinical Practice, IRB , NIH , NCI , NSF and/or other regulatory agency guidelines and seeking council from the Principal Investigator as necessary.
The incumbent is expected to closely monitor use of experimental equipment and drugs. Because some subjects referred to to participate on a research study have no other option for recovery, the incumbent must be aware of the subjects condition, well informed in the use of study material (devices, equipment, etc.) and conscientious in his/her analysis of appropriate actions.
The incumbent is responsible to organize coverage when not present to ensure protocol requirements are followed.
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.
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.
Previous experience working with clinical trials post-award financial management.
Type Benefited Staff
Special Instructions Summary
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: email@example.com 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: firstname.lastname@example.org .
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.