Job Information
University of Utah PS Clinical Site Monitor in Salt Lake City, Utah
Details
Open Date 07/03/2024
Requisition Number PRN39084B
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 President
Department 01345 - HCI Clinical Resrch Compliance
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 47600 to 75000
Close Date
Open Until Filled Yes
Job Summary
Conduct monitoring of investigator-initiated oncology clinical trials to ensure compliance to the protocol, regulations, guidance and standard operating procedures. Recommend corrections to monitoring findings and enhancements to study protocols and to operating policies and procedures. Report study progress, toxicity summary and compliance issues to the HCI Data and Safety Monitoring Committee ( DSMC ). Coordinate and oversee participation of outside sites on Huntsman Cancer Institute multi-site clinical trials.
HuntsmanCancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide. Partnerships with individuals, communities, and many other entities are crucial to our work. Huntsman Cancer Institute values cancer-related health equity, and inclusion as integral to our guiding principle to serve our patients and their communities, and our commitment to foster a culture of belonging for all within our organization.
In your cover letter or during your interview process, we invite you to share how your personal and professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position.
Learn morehere
Responsibilities
Essential Functions
Oversee, coordinate and conduct quality assurance reviews, including monitor and audit visits on cancer related clinical trials to ensure compliance with study protocol, University, state and federal guidelines.
Compile comprehensive reports for Principal Investigators, DSMC and other committees as assigned.
Administer and Support the Data and Safety Monitoring Committee.
Assist in protocol development and maintenance.
Develop, monitor, and update study specific case report forms and progress of the electronic data capture for each study.
Analyze and document compliance processes. Recommends enhancements to operating policies and procedures for compliance review. Develop departmental SOPs.
Develop, coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues.
Maintain current knowledge regarding federal and state guidance, including Good Clinical Practice ( GCP ).
Problem Solving
Incumbent is responsible for assisting the University in preparation for regulatory audits by developing, monitoring and updating quality controls and recommending actions to maintain compliance. This position is the primary contact and expert regarding regulatory agency standards governing clinical trials. Representative challenges of this position include determining the validity of collected data, assessing process shortfalls, and developing effective safeguards to reduce risk. The incumbent must possess the ability to foster collaborative working relationships with a wide range of constituencies.
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
Certified Clinical Research Professional ( CCRP , CCRC or CCRA )
Prior experience or knowledge of oncology, and oncology related research
Prior experience with Institutional Review Board ( IRB ) procedures
Strong written and oral communication skills
An understanding of University operations, policies and technology is preferred. Training or teaching experience 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.