PS Project Administrator

University of Utah; Salt Lake City (UT); Sur place; USD 45 000 - 82 000; Plein temps

Résumé du poste

University of Utah is seeking a Clinical Project Manager to coordinate oncology trials from initiation through delivery. You will build relationships with sponsors and investigators, prepare essential study documents, and ensure adherence to protocols, regulations, and clinical objectives.

The role emphasizes cross-functional leadership and data integrity across studies. The position requires oncology trial experience, knowledge of trial management software, and ability to mentor staff, manage

Qualifications

• Experience coordinating oncology trials and managing regulatory submissions.
• Familiarity with trial documentation and adverse event reporting.
• Leadership and training capabilities in research teams.

Responsabilités

• Supports Principal Investigators and staff with screening, enrollment and data submission.
• Ensures protocol compliance and quality source documents for sponsors.
• Monitors eligibility, data submission and delinquency rates; resolves issues.
• Oversees start-up activities, CSA/Feasibility and regulatory navigation.
• Develops SOPs and work practices; mentors junior staff.

Connaissances

Oncology clinical research experience

Regulatory guidelines knowledge

Clinical trial management

Team leadership

Good communication

SOCRA/ACRP awareness

Formation

Bachelor's degree or equivalent in related field

4-6 years oncology experience

Outils

Clinical Trial Management Software

Description du poste

Clinical Project Managers

This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. 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.

Job Summary

Clinical Project Managers

This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. 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.

Coordinate all aspects of clinical studies from initiation through delivery. Build and maintain relationships with sponsors, investigators, and research staff. Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. Maintain required records and ensure compliance with protocols, regulatory regulations, and overall clinical objectives. Record adverse event and side effect data and confer with investigators regarding reporting of events to oversight agencies. Utilize project management methodologies, lead cross-functional teams, resolve issues within the clinical study, and ensure that all targets, timelines, budgets, and requirements are met.

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.

Learn more about the great benefits of working for University of Utah: benefits.utah.edu

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

EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience).

Department may hire employee at one of the following job levels: Clinical Project Manager, III: Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience.

Preferences

• 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
• Bachelor's degree in a related area of assignment or equivalency and 4 - 6 years of progressively more responsible oncology experience.
• 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.
• Four to six years of progressively more responsible leadership experience. Background knowledge of hiring department's area of specialization. SOCRA or ACRP certified.

Special Instructions

Requisition Number: PRN46044B

Full Time or Part Time? Full Time

Work Schedule Summary

Department: 01167 - HCI Clinical Trials Operations

Location: Campus

Pay Rate Range: 45000 to 82000

Close Date: 11/25/2026

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