PS Study Coordinator

DetailsOpen Date 02/09/2024Requisition Number PRN37672BJob Title PS Study CoordinatorWorking Title PS Study CoordinatorJob Grade DFLSA Code AdministrativePatient Sensitive Job Code? YesStandard Hours per Week 40Full Time or Part Time? Full TimeShift DayWork Schedule SummaryVP Area U of U Health - AcademicsDepartment 00260 - Division of General SurgeryLocation CampusCity Salt Lake City, UTType of Recruitment External PostingPay Rate Range 31600 to 55621Close DateOpen Until Filled YesJob SummaryCoordinates the implementation, quality control and completion of research studies while assisting Principal Investigator(s) in determining and accomplishing study objectives. This position will assist with content development, project schedule, meeting coordination, patient enrollment and data collection while maintaining compliance with guidelines set by governing agencies.ResponsibilitiesApplicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.DisclaimerThis 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.Essential Functions1. Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.2. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines.3. Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.4. Determines length of visits and coordinates related facility and equipment availability.5. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.6. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.7. Completes, audits, corrects CRFs, relays CRFs to sponsor.8. Assists with negotiating contract budget and payment terms.9. Maintains documents as required by FDA guidelines.10. May maintain contact with IRB and prepare and submit IRB documents.11. May ensure proper collection, processing and shipment of specimens.12. May perform functions required of the Clinical Research Assistant as necessary.Problem SolvingIncumbents are responsible for coordinating the daily operations of their assigned research team, coordinating the orderly and safe flow of the research project and maintaining adequate resources for the PI to accomplish their research objectives.CommentsWork Environment and Level of Frequency that may be required Nearly Continuously: Office environment.Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting, hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking.Seldom: Bending, reaching overhead.The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient’s status and provide care as described in the department’s policies and procedures manual.Minimum QualificationsBachelor’s degree in a related field, or equivalency (one year of education can be substituted for two years of related work experience) required. IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire and demonstrated human relations and effective communication skills are also required.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.Some departments may require IATA DGR training within six months.PreferencesType Benefited StaffSpecial Instructions SummaryAdditional InformationTo inquire about this posting, email: [email protected] (%[email protected]) 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.The University of Utah values candidates who have experience working in settings with students from all backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.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:Online reports may be submitted at [email protected] more information: https://www.utah.edu/nondiscrimination/Online reports may be submitted at oeo.utah.eduFor more information: https://www.utah.edu/nondiscrimination/ https://safety.utah.edu/safetyreportThis 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.