Details
Open Date 11/13/2024
Requisition Number PRN40327B
Job Title PS Clinical Research Coord Sr.
Working Title PS 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
Monday-Friday, 8am-5pm. Hybrid of in-person and remote. To be determined with supervisor.
VP Area U of U Health - Academics
Department 00251 - Physical Med & Rehab - Oper
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 70000-83000
Close Date 02/13/2025
Job Summary
Coordinates complex clinical trial activities and plays a critical role in the conduct of multiple research studies
Responsibilities
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Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
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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.
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Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.
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Implement procedures to prevent future events, including staff education and retraining.
5.Prepare for and coordinate site visits made by sponsors or federal agencies during course and at the close of the study.
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Supervise the Regulatory Coordinator who will prepare, submit and maintain IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence.
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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 .
8.Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
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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 visits, recruitment plan, execution of research plan, collecting adverse event information, maintaining study subject documentation. Maintain records and other documentation and training.
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Helps develop applicable data management queries and oversees data cleaning activities.
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Determine subject population availability, develop recruitment, informed consents and screening materials; help develop survey and study data collection instruments.
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Evaluate new protocols for feasibility. Thorougly 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.
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Develops QA/QC processes and conduct quality control activities (field/study visits, data queries)
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Determine study visit and site/clinic work flows for studies/protocols
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Works with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs.
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Helps to develop standard operating procedures
Problem Solving
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 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.
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
Type Benefited Staff
Special Instructions Summary
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.
