PS Clinical Site Monitor

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Open Date 05/30/2024 Requisition Number PRN38702B 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

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

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 - 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.

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, 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.

Huntsman Cancer 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 more here

Responsibilities

• Oversee, coordinate and conduct routine audits on cancer related investigator-initiated clinical trials in accordance with the National Cancer Institute approved Data and Safety Monitoring Plan to ensure compliance with study protocol, University, state and federal guidelines.

• Compile comprehensive reports for Principal Investigators, the Data and Safety Monitoring Committee (DSMC) and other committees as assigned.

• Analyze and document audit process, results, and outcome. Report outcomes to the DSMC.

• Determine the validity of collected data, conduct periodic data audits, assessing process shortfalls, and developing effective safeguards to reduce risk in clinical research.

• 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.

• Serve as the primary contact and expert regarding regulatory agency standards governing clinical trials.

• Conduct quality assurance reviews on non-IIT cancer related clinical trials to ensure compliance with study protocol, university, state, and federal guidelines.

• Develop, coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues.

• 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.

• Maintain current knowledge regarding federal and state guidance, including Good Clinical Practice (GCP).

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

• 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.

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

• 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 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

• Do you have any current relatives working in HCI?

(Open Ended Question)

Applicant Documents

Required Documents

• Resume

Optional Documents

• 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