Job Information

University of Utah Clinical Site Monitor in Salt Lake City, Utah

Details

Open Date 07/29/2022

Requisition Number PRN31660B

Job Title PS Clinical Site Monitor

Working Title 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 President

Department 01345 - HCI Clinical Resrch Compliance

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 47600 to 90400

Close Date

Open Until Filled Yes

Job Summary

The Clinical Site Auditor reviews HCI Investigator Initiated Trials (IITs) for accuracy, internal consistency, and compliance with applicable regulations, standard operating procedures ( SOP ) and GCP guidelines. The auditor is a member of the Research Compliance Office and conducts audits on oncology/hematology clinical trials with varying complexity and risk levels including phase I, first in man trials. This position will have a greater emphasis working on Population Science based clinical trials.

Audits of HCI IITs are performed independent of routine study monitoring and in general, are conducted to verify the effectiveness of routine monitoring. The Auditor will verify during each audit overall compliance to the study protocol including review of subject eligibility, informed consent, disease outcome, AEs and toxicity reporting. The Auditor will also ensure regulatory documentation and completeness of essential documents, investigational drug/pharmacy records, if applicable, and data quality by auditing the electronic Case Report Forms. The Auditor reviews previous audit reports and monitoring letters to verify correction of issues/findings or to discover any recurring issues or negative trends that may exist. Additionally, the Auditor will work with the study teams to develop Corrective and Preventive Action Plans (CAPAs) when needed and ensure any findings are brought to resolution. Study subject records or research charts are audited to ensure the authenticity of study conduct and validity of study results and to ensure inspection readiness by regulatory authorities.

This position will work with external sites participating in our IITs by auditing all sites on a routine basis, obtaining access to their electronic platforms and working with external sites to ensure their internal processes are being done per SOP and study contracts. Audits are performed remotely, however travel to the sites may be required.

This job has the ability to be a hybrid schedule of remote and in office work.

Responsibilities

1. Oversee, coordinate and conduct routine audits on Population Science cancer related

investigator-initiated research in accordance with the IRB approved study plan, as well as

University, state and federal guidelines.

2. Compile comprehensive reports for Principal Investigators, the Huntsman Cancer Institute

Data and Safety Monitoring Committee ( DSMC ), if applicable, and other committees as

assigned.

3. Analyze and document audit process, results, and outcome, and depending on the study

type, report on those outcomes to the HCI DSMC

4. Determine the validity of collected data, conduct periodic data audits, assessing process

shortfalls, and developing effective safeguards to reduce risk in clinical research.

5. Recommend corrections to audit findings, assist teams in the development of CAPAs and

other enhancements to operating policies and procedures as well as study protocols.

Develop departmental SOPs.

6. Serve as the primary contact and expert regarding research compliance and regulatory

agency standards governing clinical research.

7. Conduct quality assurance reviews on non- IIT cancer related clinical trials to ensure

compliance with study protocol, university, state, and federal guidelines.

8. Develop, coordinate and participate in educational and training programs to enhance

compliance and awareness of compliance issues.

9. Work with PI and study team to ensure compliance with the protocol, GCPs, applicable

regulations and SOPs in order to protect the rights, safety and well-being of research

participants and to protect the integrity of study data.

10. Maintain current knowledge regarding federal and state guidance, including Good Clinical

Practice ( GCP ).

11. Conduct routine audits on external participating sites and work with the sites to ensure study

compliance.

12. Project manage assigned clinical trials by facilitating study team questions, study

registrations, training on the protocol and acting as a liaison to the Data and Safety

Monitoring Committee.

Minimum Qualifications

Bachelor’s degree in a health science or related field or equivalency; 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

· Prior experience working in cancer related research. Knowledge of oncology/hematology with strong understanding of medical terminology.

· An understanding of University operations, policies and technology is preferred.

Type Benefited Staff

Special Instructions Summary

Additional Information

The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.

Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are 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:

Director/ Title IX Coordinator

Office of Equal Opportunity and Affirmative Action ( OEO /AA)

135 Park Building

Salt Lake City, UT 84112

801-581-8365

oeo@utah.edu

Online reports may be submitted at oeo.utah.edu

For more information: https://www.utah.edu/nondiscrimination/

To inquire about this posting, email: employment@utah.edu (%20employment@utah.edu) or call 801-581-2300.

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.