DetailsOpen Date 06/03/2024Requisition Number PRN38731BJob Title PS Clinical Research CoordWorking Title Clinical Research CoordJob Grade EFLSA Code AdministrativePatient Sensitive Job Code? YesStandard Hours per Week 40Full Time or Part Time? Full TimeShift DayWork Schedule SummaryMonday – FridayVP Area U of U Health - AcademicsDepartment 00269 - Orthopedic Surgery OperationsLocation CampusCity Salt Lake City, UTType of Recruitment External PostingPay Rate Range $50,000 - $56,000Close DateOpen Until Filled YesJob SummaryCoordinates 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.ResponsibilitiesEssential Functions
Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
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.
Recognizes, tracks and reports adverse events and protocol deviations.
Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
Represents the research program at meetings, national and international research consortia.
Prepares, submits and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence.
Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
Supervises, mentors and trains new or junior research staff.
Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
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 requiredNearly Continuously: Hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking, standing, sitting.Seldom: Bending, reaching overhead.Minimum QualificationsBachelors degree in a health sciences or related field or equivalency (one year of education can be substituted for two years of related work experience) 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.PreferencesType Benefited StaffSpecial Instructions SummaryAdditional InformationThe 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 patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.All qualified individuals are strongly 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 ( OEO /AA). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/Online reports may be submitted at oeo.utah.eduhttps://safety.utah.edu/safetyreport This 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.