Details **Open Date** 10/16/2024 **Requisition Number** PRN40115B **Job Title** PS Clinical Research Coord Sr. **Working Title** Clinical Research Coord Sr. **Job Grade** F **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** 00868 - Psychiatry - Research **Location** Campus **City** Salt Lake City, UT **Type of Recruitment** External Posting **Pay Rate Range** $65,000 - $70,000 **Close Date** 01/16/2025 **Job Summary** This Clinical Research Coordinator ( CRC ) is responsible for the day-to-day planning, implementation, tracking and reporting for this Federally-sponsored project related to substance use disorder education of students in the University of Utah Spencer Fox Eccles School of Medicine (MD and PA students) and College of Nursing (NP students). The Clinical Research Coordinator will work with the Project Director (PD), Advisory Board (AB) and Curriculum Development Group ( CDG ) as well as internal and external partners to: 1) develop and implement a comprehensive SUD curriculum framed in a chronic illness and recovery management model that addresses the core elements recommended by SAMHSA ; 2) develop a step-by-step plan to integrate the SUD content into the general programs’ curriculum, promote SUD education in professional healthcare schools and engage students in treating SUD upon graduation; 3) assist the PD to ensure the scope and direction of the project is on schedule and within budget, required reports are prepared and submitted in a timely fashion, and the required elements of the project are achieved, including an engagement strategy and communications plan for the project. **Responsibilities** **Essential Functions:** 1. Oversee, assess and ensure participant safety and strict protocol implementation/adherence; oversee compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs. 2. Develop study budgets; monitor and billing; negotiate payment schedule and fees with sponsor. 3. Evaluate processes to identify obstacles to successful recruitment and retention of study participants. Recommend and implement innovative approaches to maximize enrollment and optimize subject retention. 4. Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks. 5. Implement procedures to prevent future events, including staff education and retraining 6. Prepare for and coordinate site visits made by sponsors or federal agencies during course and at the close of the study. 7. Represent the research program at meetings, national and international research consortia. 8. Prepare, submit and maintain IRB , SAMHSA and/or other regulatory documents and research correspondence 9. Assist in the selection and hiring process for study staff; supervise, mentor and train new or junior research staff; provide direction and oversee preparation of study staff for monitoring visits; manage staff schedules ensuring shift/studies are covered; approve requests for time off/approve KRONOS . 10. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues. 11. Develop training and staff certification materials, procedures and requirements. Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study. Oversee and train team members across the entire spectrum of research studies to include, but not limited to: protocol requirements, schedule of visits, recruitment plan, execution of research plan, collecting adverse event information, maintaining study subject documentation. Maintain records and other documentation of training. 12. Helps develop applicable data management queries and oversees data cleaning activities. 13. Determine subject population availability, develop recruitment, informed consents and screening materials; help develop survey and study data collection instruments 14. Evaluate new protocols for feasibility. Thoroughly review study protocols and map process and data flow to predict areas of vulnerability. Identify, recommend and implement solutions to address such vulnerabilities in specific trials and across the team’s study portfolio. 15. Coordinate approval of new study agreements and contracts; assists in the development of case report forms. 16. Develops QA/QC processes and conduct quality control activities (field/study visits, data queries) 17. Determine study visit and site/clinic work flows for studies/protocols 18. Works with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs 19. Helps to develop standard operating procedures 20. Compiles information for grant applications 21. Participates in abstract and manuscript preparation. 22. Assure that goals, objectives and deliverables of the specific grant are met accurately and on time, 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** Bachelor’s degree in a health science **or** related field or equivalency (one year of education can be substituted for two years of related work experience); plus, 4 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. Care is appropriate to the population served Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description. **Preferences** A related Master’s degree may be preferred. Experience and familiarity with University of Utah systems, policies, and procedures. 1-2 years of federal grant management experience. Skills and knowledge: Demonstrated human relations and effective communications skills. Demonstrated potential ability to perform the essential functions of the job as outlined in the position description. **Type** Benefited Staff **Special Instructions Summary** **The main duties will be in Salt Lake City, UT on the campus of the University of Utah. A combination of in-person, in-office work, site visits and remote telework will be required during the daytime hours, Monday through Friday. The candidate 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 Telecommuting Agreement. Local travel to clinical sites in the Salt Lake City area will be required by personal vehicle. One to two overnight out of town trips per year may be required as the travel budget allows.** **Additional Information** 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 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.edu https://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.