PS Project Administrator

University of Utah; Salt Lake City (UT); On-site; USD 60,000 - 90,000; Full time

Job summary

The University of Utah is seeking an Oncology Clinical Research Coordinator to oversee administrative, financial, personnel, and technical functions within an assigned department. You will coordinate study activities, support investigators, and ensure regulatory and data standards across trials in an academic hospital setting.

The role requires a Bachelor’s in a related field, 3+ years of oncology research coordination, and strong communication skills.

Qualifications

• Bachelor’s degree in Business Administration, Accounting, or related field; Master’s degree preferred.
• Four years of progressively responsible related experience; strong communication skills.
• Patient-sensitive position; immunization per CDC standards may be required.

Responsibilities

• Supports PI and study staff with patient screening, eligibility review, data submission, and trial maintenance.
• Ensures quality source documents and data for sponsors; maintains protocol compliance.
• Monitors eligibility, protocol requirements, data submission; tracks delinquency and query resolutions.
• Oversees monitoring/auditing reports; resolves issues with staff in a timely manner.
• Mentors and trains new or junior research staff; ensures adequate team coverage.
• Develops educational materials and evaluation tools for teams; supports start-up activities.
• Develops, implements and enforces SOPs and Work Practice Documents.
• Oversees AE/SAE reporting and deviation reporting to sponsors and IRB.
• Manages workflow; reviews staff performance and revises procedures as needed.
• Assumes additional assignments as directed by the Program Manager.

Skills

Oncology clinical research coordinates

Regulatory compliance

Data management

Team supervision

CTMS experience

Education

Bachelor's degree in Business Administration / Accounting / related field

Master's degree preferred

Tools

Clinical Trial Management Software

Job description

Priority Review Date (Note - Posting may close at any time)

Job Summary

Oversees all administrative, financial, personnel, and technical functions of a program in an assigned department. Organizes and assigns duties to employees and advises the departmental administrators of the program’s activities.

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.

Responsibilities

Applicants must demonstrate the potential ability to perform essential job functions:

• Supports Principal Investigators (PI) and study management staff with patient screening/enrollment, eligibility review, data submission, and overall maintenance of new and ongoing clinical trials.
• Ensures study management staff are providing quality source documents and data to sponsors, while ensuring protocol compliance is maintained within regulatory guidelines and standards.
• Routinely monitor and ensure compliance with eligibility, protocol requirements, data submission completion while monitoring delinquency rates, outstanding query resolutions
• Ensure monitoring/auditing reports and outstanding issues with staff are identified, addressed, and resolved in appropriate timeframe while providing direction and oversight.
• Provides assistance with personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans.
• Contribute to developing educational materials on coordination and data completion processes and requirements for the teams, as well as evaluation and education tools to assess staff competency.
• Assist with study start up and oversee workload resourcing for team while providing primary point of contact support for completion of start-up activities (i.e., initiating CDA , Feasibility, MDG scoring and navigation of review committees required for activation, etc.).
• Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs)
• Oversee and ensure completeness in appropriate AE and SAE reporting requirements as well as Deviation reporting to sponsors and the IRB .
• Manages the workflow by reviewing staff performance through period performance and salary reviews and revising the operating procedures as needed.
• OTHER : Assume responsibility for additional assignments as directed by the Program Manager

Minimum Qualifications

Bachelor’s degree in Business Administration, Accounting, or a related field, or equivalency (one year of education can be substituted for two years of related work experience); four years of progressively more responsible related experience; and demonstrated human relation and effective communications skills required. A related Master’s degree preferred.

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

• Background knowledge of assigned department’s area of specialization in order to analyze, plan, train and draw conclusions for recommendations to Clinical Trial Manager. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop team and to ensure the smooth operation of department.
• Completion of provided supervisory/management training within one year of employment may be required.

Successful candidates will have:

• Three years of Oncology Clinical Research Coordinator Experience
• Advanced knowledge and understanding of regulatory guidelines related to human subject research protections in clinical trial investigations
• Clinical Trial Management Software experience
• Ability to assess functional processes, workflow and develop improvements for efficiency and quality output.
• Advanced knowledge of industry standards related to clinical trial coordinator functions and study data management activities; (i.e., complex trial designs, data standards, data reviews, etc.).
• Demonstrated ability to positively influence others in a team environment

Type

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 [phone] 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 [phone] or [phone] or University Human Resource Management at [phone] 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 possess a strong commitment to improving access to higher education.

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.

Consistent with state and federal law, the University of Utah 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 Title IX ( OEO ). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at the: University of Utah Non‑Discrimination page.

Online reports may be submitted at https://oeo.utah.edu

https://publicsafety.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.

As per University of Utah policy 5-108: Transfer of Benefits Eligible Staff Members , a new hire to the University of Utah who is still serving a 12 month probationary period will not be hired into another University of Utah job (a transfer) until the successful completion of the probationary period.

Required Documents

• Resume
• Cover Letter

Optional Documents

• Historical Only – Do Not Use – See Document Description for More Information – Addendum to the University of Utah – Veteran Only
• Historical Only – Do Not Use – See Description for More Information – Appropriate discharge document (such as DD-2214) – Veteran Only

University Human Resource Management
250 East 200 South, Suite 125 Salt Lake City, UT 84111
Contact us: [phone] By Email: [e-mail]