Job Information
University of Utah PS Clinical Site Monitor in Salt Lake City, Utah
Details
Open Date 04/25/2024
Requisition Number PRN38366B
Job Title PS Clinical Site Monitor
Working Title PS Clinical Site Monitor
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 00224 - Internal Medicine Admin
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 47600 to 84249
Close Date
Open Until Filled Yes
Job Summary
Oversees, coordinates and conducts monitoring reviews of clinical trials and clinical research projects within the Department of Internal Medicine. Position provides independent regulatory oversight of all aspects of study conduct at the site, institutional, or network level. Ensures compliance with University policies, Food and Drug Administration ( FDA ) and Office of Human Research Protection ( OHRP ) regulations, Good Clinical Practice ( GCP ), and state and federal guidelines. Expertise in human subject research and experience working with the FDA and ICH GCP are required. Independently performs all on-site or remote monitoring activities.
Responsibilities
Monitors clinical studies in accordance with FDA regulations, ICH guidelines, IRB policies, University of Utah clinical research SOPs, protocol specifications and monitoring plan. Recognize protocol deviations and other study related issues and work to resolve and/or make appropriate recommendations for correction. Reviews investigational product or device accountability site records for completeness and accuracy. Analyzes and documents monitoring findings and creates monitoring reports.
Reviews site monitoring reports and discusses findings with clinical trial teams and study Investigators. Provides guidance for appropriately returning the clinical study to full regulatory compliance.
Works directly with Principal Investigators during protocol development. Provides in-depth review of and suggestions for investigator initiated trial ( IIT ) protocols. Assists in drafting study monitoring and DSMC plans.
Works closely with the rest of QA team to develop, monitor, and update quality control systems for tracking compliance activities. Identifies issues, trends, and risk areas. Recommends improvements to operating policies and procedures.
Develops, coordinates, and participates in educational and training programs to promote compliance and enhance awareness of compliance issues. Conducts in-person training on an individual, department, institutional, and multi-institutional level.
Teams up with faculty and staff to assist investigators, sites, divisions and departments in implementing compliance practices and monitors and coordinates those activities with the departments.
Problem Solving:
The incumbent decides how to best accomplish the daily requirements of various monitoring objectives, prioritizes workload and establishes systems needed to achieve specific goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow-through and compliance of all involved. Functions under minimal supervision, following FDA , GCP , IRB , NIH , and any other relevant regulatory agency policies, regulations and guidelines. Must be able to independently make decisions regarding study procedures and protocol issues as well as recognize and resolve protocol deviations.
Comprehensive Benefits include, but are not limited to:
11 paid Holidays per year
Free UTA public transportation pass
For the majority of employees, the University contributes an amount equal to 14.2% of pay to a 401(a) Retirement Plan.
Basic Life Insurance provided up to $25,0000
50% tuition reduction if qualified.
Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
Health coverage options with possible additional premium discount via wellness program
Paid parental leave, above vacation & sick accruals, if qualified
Professional development training opportunities.
More information found athttps://www.h
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); and four years of clinical research experience that includes regulatory compliance monitoring/auditing, IRB application submission, and experience in human subjects research. Must have a working knowledge of FDA , ICH , and other regulatory compliance; an understanding of medical terminology and technical writing experience. Excellent interpersonal communication (including oral and written) and leadership skills also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs.
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.
Preferences include credentialing as a Certified Clinical Research Associate ( CCRA ), Certified Clinical Research Coordinator ( CCRC ), and/or Certified Clinical Research Professional ( CCRP ). Prior experience as an industry CRA or Monitor is also preferred.
Hiring department may require certification by an appropriate certifying body within two years of hire.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Preferences
Bachelor’s degree in Health Care related field plus five years regulatory or clinical trials experience preferred. Prior experience working with Industry or as a monitor is also preferred.
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.