University of Utah

Department 02059 - HCI Popul Sci Trials Office Job Summary

We are excited to add another member to our Population Sciences Research Infrastructure Systems and Management Population Sciences Trials Office and Adapt team! Our PRISM PSTO/Adapt staff are involved in research studies associated with population sciences based research at Huntsman Cancer Institute. If you are passionate about contributing to HCI’s vision of delivering a cancer free frontier, this is the role for you!

The new member will be responsible for managing research projects and staff. The program manager will support principal investigators and staff through the project life cycle from start to end. This work may include supporting investigator-initiated studies and sponsored projects.

This position is eligible for university benefits. These benefits include:

• Medical-dental-wellness coverage: https://www.hr.utah.edu/benefits/health\_wellness.php
• An immediately vested 14.2% of salary employer contribution to retirement (401a): https://www.hr.utah.edu/benefits/retire\_401aPlan.php
• Paid leave: https://www.hr.utah.edu/benefits/paidLeave.php
• Paid holidays: https://www.hr.utah.edu/benefits/holiday.php
• Tuition assistance for employees and family: https://www.hr.utah.edu/benefits/tuition.php
• Free UTA transport pass: https://commuterservices.utah.edu/uta/
• See details about these benefits and others at: https://www.hr.utah.edu/benefits/
• Total Compensation Calculator

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.

In your cover letter or during your interview process, we invite you to share how your 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.

Responsibilities

Administration

• Serve as liaison/point of contact between study sponsor, investigators, study coordinators as well as regulatory or finance where applicable
• Participate in Canvas Update Working Group for the implementation and oversight of the training program and platform
• Provide feedback on policies and procedures for investigator services, staff management and budgetary goals/objectives
• Market and promote PSTO/Adapt services
• Facilitate relationships with the community and across the University of Utah and Huntsman Cancer Institute
• Develop strategies for continuous quality improvement
• Project management duties and tasks for PSTO/Adapt studies
• Organize UBox
• Represent the research program at meetings, national and international research consortia.
• Correspond with appropriate parties to execute agreements (CTA’s, CDA’s, DTA’s, etc.).
• Assist in development and implementing strategic initiatives for PSTO/Adapt.
• May be assigned other duties as needed based on department need.

Study Operations

• Manage overall research studies from start-up to completion.
• Coordinate program activities across multiple studies.
• Foster collaboration and communication, ensure investigator satisfaction
• Evaluate the needs of each site for studies
• Coordinate Oncore setup with regulatory and finance personnel
• Develop work practice documents and review standard operating procedures
• Build study templates
• Ensure adherence to ICH Guidelines, Code of Federal Regulations and Standard Operating Procedures.
• Attend study meetings
• Update Ubox folders for studies as needed and moves studies to ‘completed’ status when applicable.
• Create ‘fast facts’ sheets and checklists
• Provide back-up for study team
• Update investigators on study progress.
• Primary contact with the data personnel and coordinate data build.
• Coordinating PACS access for staff when needed

Finance

• Allocate resources effectively within programs.
• Frequently meet with finance teams for study invoicing
• Review and provide input on study budgets to completion
• Primary contact with finance team.

Regulatory

• Supervise coordination compliance across studies
• Primary contact with regulatory.
• Address regulatory issues.
• Implement best practices.
• Create and/or review study documents, except the informed consent, for IRB submissions
• Document amendment changes needed for ERICA.
• Gather and review study documents for IRB approval

Supervision

• Report to PSTO/Adapt Clinical Research Manager
• Provide guidance and support to study coordinators and clinical research coordinators.
• Supervise PSTO and ADAPT study and clinical research coordinators but not limited to the following:
  • Assist in interviews
  • Performance management
  • 1:1’s
  • Kronos
  • Time off approval
  • Complete annual reviews and probationary meetings as needed
  • Provide training, mentorship and guidance to study coordinators and clinical research coordinators to ensure comprehensive completion and compliance with their job responsibilities.
• Assist with monitoring study effort reports, metrics and evaluate workload for and research staff bandwidth for individuals listed above.

Onboarding/Training

• Ensure competency of staff through education programs and informing clinical research manager of any performance management concerns
  • Include clinical research manager on all performance concerns and escalate for the clinical research manager to address after second occurrence.
• Train coordinators on study-related tasks and documentation.
• Ensure training requirements are met for coordination.

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.

Work Environment and Level of Frequency that may be required

Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Sitting, hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking.

Seldom: Bending, reaching overhead.

The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on their assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient’s status and provide care as described in the department’s policies and procedures manual.

Minimum Qualifications

Bachelor’s degree in a related area or equivalency (one year of education can be substituted for two years of related work experience). Four to six years of progressively more responsible management experience. Background knowledge of hiring department’s area of specialization in order to analyze, plan and draw conclusions for recommendations to superiors. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop subordinates and to ensure the smooth operation of department. Completion of provided supervisory training within one year of employment may be required. Master’s degree in a related area may be preferred.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

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

• A minimum of 4 years of clinical research experience is strongly preferred.
• Excellent communication, critical thinking and interpersonal skills.
• Excellent organization and attention to detail.
• Ability to work as part of a team and independently.
• Experience in a healthcare setting or health care certification.
• Experience with health and research specific electronic data capture systems.

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.

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