Details

　　Open Date 01/22/2024

　　Requisition Number PRN37482B

　　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 90400

　　Close Date

　　Open Until Filled Yes

　　Job Summary

　　This position will provide project management and clinical monitoring support for multisite trials coordinated by the Huntsman Cancer Institute Research Compliance Office from trial start-up through trial closeout. The incumbent will act as a liaison between the external clinical sites, the Research Compliance Office, sponsors/agencies and the Principal Investigators to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory guidelines. As a member in the Research Compliance Office department, the candidate will also be responsible for quality assurance oversight of clinical trials via monitoring and auditing trials and reporting study progress to the Data Safety Monitoring Committee ( DSMC ).

　　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 (https://healthcare.utah.edu/huntsmancancerinstitute/about-us/equity-diversity-inclusion)

　　Responsibilities

　　Preferred Qualifications

　　· Experience in the management of clinical trials and the investigator initiated clinical development process.

　　· Oncology clinical trial experience highly preferred.

　　· Working knowledge of Food and Drug Administration ( FDA ) requirements, Office of Human Research Protection ( OHRP ), International Conference of Humanization ( ICH ) Good Clinical Practice ( GCP ), as well as state and federal guidelines.

　　· Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines.

　　· Strong attention to detail, establishing priorities, and adhering to deadlines.

　　· Able to show initiative and work independently, take initiative and complete tasks to meet deadlines.

　　· Excellent interpersonal communication (including oral and written) and leadership skills also required.

　　· Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools.

　　Essential Functions:

　　1. Develop and maintain site feasibility packets, multisite study procedural manuals, and other multisite process documents.

　　2. Prepare clinical sites for study start-up by conducting site initiation visits.

　　3. Oversee, coordinate and conduct monitoring of clinical investigations to ensure compliance with University, Food and Drug Administration ( FDA ), Office of Human Research Protection ( OHRP ), Good Clinical Practice ( GCP ), state and federal guidelines.

　　4. Responsible for performing on-site and/or remote monitoring activities independently.

　　5. Analyze and document monitoring processes for all activities in the conduct of the clinical investigation, and recommend improvements to operating policies and procedures for compliance review. Monitor and follow up on required documentation related to audit processes.

　　6. Analyze and evaluate data gathered during research. Identify data discrepancies and missing data in source records or CRF’s.

　　7. Recognize protocol deviations and other study related issues and work to resolve and/or make appropriate recommendations for correction and full resolution.

　　8. Perform dual review of eligibility to verify that potential clinical trial participants meet protocol specific eligibility criteria and provided informed consent according to federal and IRB regulatory guidelines.

　　9. Performs on-site and remote monitoring activities of clinical research studies, as needed.

　　10. Monitor adverse events for seriousness and facilitate the AE/ SAE reporting process to ensure that all adverse events are reported to the study supporter and all participating site IRB’s.

　　11. Process new study subject registrations prior to enrollment.

　　12. Communicate with external sites determinations made on behalf of the DSMC .

　　13. Oversees the maintenance and organization of project documentation and records.

　　14. Act as a liaison between the external clinical site(s), HCI parties (PI, regulatory team, study team, etc.) study sponsors and/or regulatory agencies and the research compliance office to resolve any issues that may arise throughout the course of the study.

　　15. Provides guidance and training to research faculty and staff pertaining to complex and highly specialized rules and regulations including complex protocol, multisite trials and IND / IDE issues.

　　16. Assists in the development of policies, procedures and process improvements for departmental implementation and guidance for external associates.

　　17. Other responsibilities may include but are not limited to; updating and revision of SOPs, training and orientation of study staff, organization of coordinator/investigator meetings.

　　18. Perform other duties as assigned by management.

　　Problem Solving

　　This position utilizes federal, institutional guidelines and requirements to inform and complete submission of regulatory documents. This position also negotiates with University research committees and sponsors to ensure full compliance and communication.

　　The incumbent decides how to best accomplish the daily requirements of various regulatory 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 following FDA , Good Clinical Practice, IRB , NIH , and/or other regulatory agency guidelines. Incumbent will be responsible for resolving and/or making appropriate recommendations for correction or full resolution to the Director and other members of the management team.

　　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

　　To inquire about this posting, email: [email protected] (%[email protected]) 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.

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

　　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:

　　Online reports may be submitted at [email protected]

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

　　Online reports may be submitted at oeo.utah.edu

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