PS Clinical Site Monitor

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Open Date 07/09/2024 Requisition Number PRN39135B 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

Arranged with Supervisor

VP Area U of U Health

• Academics Department 02148

• Clinical Research Service Ofc Location Campus City Salt Lake City, UT Type of Recruitment External Posting Pay Rate Range $69,000- $80,000 Close Date Open Until Filled No Job Summary

The Clinical and Translational Sciences Institute (CTSI) is seeking a highly motivated individual to join our team providing QA and compliance support for the Clinical Research Support Office (CRSO) ensuring continuity and increasing efficiencies between the different Departments and study teams.

The Clinical Site Monitor will perform on-site and remote monitoring of moderate-high-risk clinical studies. Oversees, coordinates, and conducts monitoring reviews of multiple clinical research projects within the University of Utah. Position provides independent regulatory oversight of all aspects of study conduct at the site, or institutional level. Ensures compliance with University policies and state and Federal regulations. Expertise in human subject research and experience working with the FDA and ICH GCP regulations are required. Must have the ability to Independently perform all on-site or remote monitoring activities.

Responsibilities

Essential Functions:

• Monitor clinical studies following FDA regulations, ICH guidelines, IRB policies, protocol specifications, and monitoring plans.

• Reviews investigational product accountability records for accuracy. Analyzes and documents monitoring review findings and creates monitoring reports.

• Review site monitoring reports and discuss findings with clinical study teams and Investigators. Guides appropriately returning the clinical study to full regulatory compliance.

• Works in collaboration with the Office of Research Integrity and Compliance, Huntsman Cancer Institute, and Internal Medicine along with other Departments campus-wide to develop campus-wide processes and procedures.

• Works closely with the CRSO 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.

• Participates in educational and training programs to promote compliance and enhance awareness of compliance issues.

• Assist in conducting 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.

Disclaimer

This 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.

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 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.

Posting Specific Questions

Required fields are indicated with an asterisk (*).

• Do you have a related Bachelor's degree or equivalency? (2 years related work experience may be substituted for 1 year of education)

• Yes

• No

• How many years of clinical research experience do you have?

• Less than 1 year

• 1 year or more, but less than 2 years

• 2 years or more, but less than 4 years

• 4 years or more, but less than 6 years

• 6 years or more

Applicant Documents

Required Documents

Optional Documents

• Resume

• Cover Letter

• Appropriate discharge document (such as a DD-214 - Member Copy 4)

• Veteran Only

• Call 801.581.2169

• Addendum to the University of Utah

• Veteran Only

• Call 801.581.2169 after submission